New Drugs / Therapies

New Drugs / Therapies

Below you will find information and links to new cancer therapies or recent FDA changes of approvals of medication offered by NOS Corporate Members! P.I. Drugs and Products will stay online for 12 months from approval date.  Updated 05/29/2020 CCG

 

Corporate Member Update: Pfizer-BAVENCIO®

BAVENCIO®
July, 2020

Pfizer is pleased to announce that on June 30, 2020 the U.S. Food and Drug Administration (FDA) approved BAVENCIO® (avelumab) Injection 20 mg/mL for a new indication.  BAVENCIO is co-developed and co-commercialized by EMD Serono and Pfizer Inc.

Please  refer to the revised  Full Prescribing Information for BAVENCIO.

 

Corporate Member Update-Seattle Genetics: A product-specific J-code for an mUC treatment is now available

PADCEV™
July, 2020

We are sending this communication on behalf of Astellas Pharma US, Inc. and Seattle Genetics to announce the assignment of a product-specific, permanent J-code for PADCEV. The Centers for Medicare & Medicaid Services (CMS) released the July 2020 Quarterly Healthcare Common Procedural Coding System (HCPCS) File, which includes the designation of J9177 for PADCEV with the effective date of July 1, 2020.

Read the full press release.

Corporate Member Update: AstraZeneca-New FDA Approval for Treatment of Metastatic Castration-Resistant Prostate Cancer

LYNPARZA®
June, 2020

The US Food and Drug Administration (FDA) approved a new indication for LYNPARZA® (olaparib), as a treatment option for adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with enzalutamide or abiraterone. Patients will be selected for therapy based on an FDA-approved companion diagnostic for LYNPARZA.1

The approval was based on results from the Phase III PROfound trial, published in the New England Journal of Medicine, which showed LYNPARZA reduced the risk of disease progression or death by 66% (equal to a hazard ratio of 0.34 and p-value of <0.0001) and improved radiographic progression-free survival (rPFS) to a median of 7.4 versus 3.6 months with enzalutamide or abiraterone in men with BRCA1/2 or ATM gene-mutated mCRPC.1 Additionally, results showed:

A statistically significant improvement in the select secondary endpoint of overall survival (OS) in men with BRCA1/2 or ATM gene-mutated mCRPC. LYNPARZA reduced the risk of death by 31% (equal to a hazard ratio of 0.69 and p-value 0.0175) and improved OS to a median of 19.1 months versus 14.7 months for those treated with enzalutamide or abiraterone.1
A statistically significant improvement in objective response rate of 33% in men with BRCA1/2 or ATM gene-mutated mCRPC treated with LYNPARZA vs 2% treated with enzalutamide or abiraterone (p-value of <0.0001).1
In men with HRR-mutated mCRPC, LYNPARZA reduced the risk of disease progression or death by 51% (equal to a hazard ratio of 0.49 and p-value of <0.0001) and improved rPFS to a median of 5.8 months versus 3.5 months with abiraterone or enzalutamide.1

Fatal adverse reactions occurred in 4% of patients treated with LYNPARZA.  These included pneumonia (1.2%), cardiopulmonary failure (0.4%), aspiration pneumonia (0.4%), intestinal diverticulum (0.4%), septic shock (0.4%), Budd-Chiari Syndrome (0.4%), sudden death (0.4%), and acute cardiac failure (0.4%).1 Serious adverse reactions occurred in 36% of patients receiving LYNPARZA. Serious adverse reactions in ≥2% were anemia (9%), pneumonia (4%), pulmonary embolism (2%), fatigue/asthenia (2%), and urinary tract infection (2%).1

The most common adverse reactions (Grade 1-4) occurring in ≥10% in the LYNPARZA arm (N=256) were anemia (46%), nausea (41%), fatigue including asthenia (41%), decreased appetite (30%), diarrhea (21%), vomiting (18%), thrombocytopenia (12%), cough (11%) and dyspnea (10%).1

In addition, venous thromboembolic events, including pulmonary embolism, occurred in 7% of patients with metastatic castration-resistant prostate cancer who received LYNPARZA plus androgen deprivation therapy (ADT) compared to 3.1% of patients receiving enzalutamide or abiraterone plus ADT in the PROfound study. Patients receiving LYNPARZA and ADT had a 6% incidence of pulmonary embolism compared to 0.8% of patients treated with ADT plus either enzalutamide or abiraterone.1

This is the seventh indication approved for LYNPARZA in the US, making it the first targeted therapy in men with metastatic castration-resistant prostate cancer with HRR gene mutations to be approved by the FDA based on a Phase III trial. LYNPARZA is associated with serious, potentially fatal risks, including myelodysplastic syndrome/acute myeloid leukemia (MDS/AML), pneumonitis and venous thromboembolic events. LYNPARZA can also cause fetal harm. Please see additional Important Safety Information below.

Having this new treatment option for certain patients with metastatic castration-resistant prostate cancer addresses a continued unmet medical need for this patient population and further allows the treatment team to individualize patient care.

For more information regarding the approval, please see AstraZeneca’s press release announcing the news here.

For more information about LYNPARZA including Important Safety Information, please see below.

IMPORTANT SAFETY INFORMATION

LYNPARZA may cause serious side effects, including:

Bone marrow problems called Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML). Some people who have ovarian cancer or breast cancer and who have received previous treatment with chemotherapy, radiotherapy, or certain other medicines for their cancer have developed MDS or AML during treatment with LYNPARZA. MDS or AML may lead to death. If you develop MDS or AML, your healthcare provider will stop treatment with LYNPARZA.

Symptoms of low blood cell counts are common during treatment with LYNPARZA, but can be a sign of serious bone marrow problems, including MDS or AML. Symptoms may include weakness, weight loss, fever, frequent infections, blood in urine or stool, shortness of breath, feeling very tired, bruising or bleeding more easily.

Your healthcare provider will do blood tests to check your blood cell counts:

  • before treatment with LYNPARZA
  • every month during treatment with LYNPARZA
  • weekly if you have low blood cell counts that last a long time. Your healthcare provider may stop treatment with LYNPARZA until your blood cell counts improve

Lung problems (pneumonitis). Tell your healthcare provider if you have any new or worsening symptoms of lung problems, including shortness of breath, fever, cough, or wheezing. Your healthcare provider may do a chest x-ray if you have any of these symptoms. Your healthcare provider may temporarily or completely stop treatment if you develop pneumonitis. Pneumonitis may lead to death.

Blood clots (Venous Thromboembolic Events). Some people with prostate cancer who take LYNPARZA along with gonadotropin-releasing hormone (GnRH) analog therapy may develop a blood clot in a deep vein, usually in the leg (venous thrombosis) or a clot in the lung (pulmonary embolism). Tell your healthcare provider if you have any symptoms such as pain or swelling in an extremity, shortness of breath, chest pain, breathing that is more rapid than normal (tachypnea), or heart beats faster than normal (tachycardia). Your healthcare provider will monitor you for these symptoms and may prescribe blood thinner medicine.

Before taking LYNPARZA, tell your healthcare provider about all of your medical conditions, including if you:

  • have lung or breathing problems
  • have kidney problems
  • are pregnant, become pregnant, or plan to become pregnant. LYNPARZA can harm your unborn baby and may cause loss of pregnancy (miscarriage)
    • If you are able to become pregnant, your healthcare provider may do a pregnancy test before you start treatment with LYNPARZA
    • Females who are able to become pregnant should use effective birth control (contraception) during treatment with LYNPARZA and for 6 months after the last dose of LYNPARZA. Talk to your healthcare provider about birth control methods that may be right for you. Tell your healthcare provider right away if you become pregnant or think you might be pregnant following treatment with LYNPARZA
    • Males with female partners who are pregnant or able to become pregnant should use effective birth control (contraception) during treatment with LYNPARZA and for 3 months after the last dose of LYNPARZA
    • Do not donate sperm during treatment with LYNPARZA and for 3 months after your final dose
  • are breastfeeding or plan to breastfeed. It is not known if LYNPARZA passes into your breast milk. Do not breastfeed during treatment with LYNPARZA and for 1 month after receiving the last dose of LYNPARZA. Talk to your healthcare provider about the best way to feed your baby during this time

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking LYNPARZA and certain other medicines may affect how LYNPARZA works and may cause side effects.

How should I take LYNPARZA?

  • Take LYNPARZA tablets exactly as your healthcare provider tells you
  • Do not change your dose or stop taking LYNPARZA unless your healthcare provider tells you to. Your healthcare provider may temporarily stop treatment with LYNPARZA or change your dose of LYNPARZA if you experience side effects
  • Your healthcare provider will decide how long you stay on treatment
  • Do not take more than 4 LYNPARZA tablets in 1 day. If you have any questions about LYNPARZA, talk to your healthcare provider or pharmacist
  • Take LYNPARZA by mouth 2 times a day
  • Each dose should be taken about 12 hours apart
  • Swallow LYNPARZA tablets whole. Do not chew, crush, dissolve, or divide the tablets
  • Take LYNPARZA with or without food
  • If you are taking LYNPARZA for prostate cancer and you are receiving gonadotropin-releasing hormone (GnRH) analog therapy, you should continue with this treatment during your treatment with LYNPARZA unless you have had a surgery to lower the amount of testosterone in your body (surgical castration)
  • If you miss a dose of LYNPARZA, take your next dose at your usual scheduled time. Do not take an extra dose to make up for a missed dose
  • If you take too much LYNPARZA, call your healthcare provider or go to the nearest hospital emergency room right away

What should I avoid while taking LYNPARZA?

Avoid grapefruit, grapefruit juice, Seville oranges, and Seville orange juice during treatment with LYNPARZA since they may increase the level of LYNPARZA in your blood.

LYNPARZA may cause serious side effects (see above). The most common side effects of LYNPARZA are:

  • nausea or vomiting. Tell your healthcare provider if you get nausea or vomiting. Your healthcare provider may prescribe medicines to treat these symptoms
  • tiredness or weakness
  • low red blood cell counts
  • diarrhea
  • loss of appetite
  • headache
  • low white blood cell counts
  • changes in the way food tastes
  • cough
  • shortness of breath
  • dizziness
  • indigestion or heartburn
  • low platelet counts
  • upper stomach area (abdominal) pain

These are not all the possible side effects of LYNPARZA. Call your healthcare provider for medical advice about side effects.

You may report side effects related to AstraZeneca products by clicking here. If you prefer to report these to the FDA, either visit www.FDA.gov/medwatch or call 1-800-FDA-1088.

WHAT IS LYNPARZA?

LYNPARZA is a prescription medicine used to treat adults who have:

  • advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer with a certain type of inherited (germline) or acquired (somatic) abnormal BRCA gene. LYNPARZA is used alone as maintenance treatment after the cancer has responded to your first treatment with platinum-based chemotherapy. Your healthcare provider will perform a test to make sure that LYNPARZA is right for you
  • advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer with a certain type of abnormal BRCA gene or a positive laboratory tumor test for genomic instability called HRD. LYNPARZA is used in combination with another anti-cancer medicine, bevacizumab, as maintenance treatment after the cancer has responded to your first treatment with platinum-based chemotherapy. Your healthcare provider will perform a test to make sure that LYNPARZA is right for you
  • ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, as maintenance treatment, when the cancer has come back. LYNPARZA is used after the cancer has responded to treatment with platinum-based chemotherapy
  • advanced ovarian cancer with a certain type of abnormal inherited BRCA gene, and have received treatment with 3 or more prior types of chemotherapy medicines. Your healthcare provider will perform a test to make sure that LYNPARZA is right for you
  • a certain type of abnormal inherited BRCA gene, human epidermal growth factor receptor 2 (HER2)-negative breast cancer that has spread to other parts of the body (metastatic). You should have received chemotherapy medicines, either before or after your cancer has spread. If you have hormone receptor (HR)-positive disease, you should have been treated with hormonal therapy. Your healthcare provider will perform a test to make sure that LYNPARZA is right for you
  • metastatic pancreatic cancer with a certain type of abnormal inherited BRCA gene.  LYNPARZA is used as a maintenance treatment after your cancer has not progressed on at least 16 weeks of treatment with platinum-based chemotherapy. Your healthcare provider will perform a test to make sure LYNPARZA is right for you
  • prostate cancer with certain inherited or acquired abnormal genes called homologous recombination repair (HRR genes). LYNPARZA is used when the cancer has spread to other parts of the body (metastatic), and no longer responds to a medical or surgical treatment that lowers testosterone, and has progressed after treatment with enzalutamide or abiraterone. Your healthcare provider will perform a test to make sure LYNPARZA is right for you

It is not known if LYNPARZA is safe and effective in children.

Please click here for complete Prescribing Information, including Patient Information (Medication Guide).

 

For more information, please visit www.lynparzahcp.com

If you have any questions, please do not hesitate to contact CJ Akers at (262) 893-7322.

Corporate Member Update: Novartis-ADAKVEO®

ADAKVEO®
June, 2020

Novartis is pleased to announce that for dates of service on or after July 1, 2020, the Centers for Medicare and Medicaid Services (CMS) has issued a product-specific J-code: J0791 for injection, crizanlizumab-tmca, 5 mg. The updated billing unit is 5 mg.

The new and unique J-code replaces all previous HCPCS codes for ADAKVEO® (crizanlizumab-tmca) for IV Infusion 10 mg/mL.  The permanent J-code is used by all payer types.

Please note: For dates of service before July 1, 2020, use either J3490 (unclassified drugs, all sites of care) or J3590 (unclassified biologics, all sites of care). For dates of service between April 1, 2020, and June 30, 2020, some payers may allow the use of C9053 (Injection, crizanlizumab-tmca, 1 mg, Hospital outpatient).

Important billing and coding information:

ADAKVEO is supplied as a solution in a single-dose vial. See below for coding details:

·     1 unit = 5 mg

·     The JW modifier must be used to report the amount of drug in single-dose or single-use packaging that is discarded and eligible for payment

Should you have any questions, please John Zaiger at 817.313.0041


Indication

ADAKVEO® (crizanlizumab-tmca) is indicated to reduce the frequency of vaso-occlusive crises (VOCs) in adults and pediatric patients, aged
16 years and older, with sickle cell disease.

Important Safety Information Infusion-Related Reactions

In the SUSTAIN clinical trial, infusion-related reactions (defined as occurring within 24 hours of infusion) were observed in 2 (3%) patients treated with ADAKVEO 5 mg/kg. Monitor patients for signs and symptoms of infusion-related reactions, which may include fever, chills, nausea, vomiting, fatigue, dizziness, pruritus, urticaria, sweating, or shortness of breath or wheezing. Discontinue ADAKVEO infusion for severe reactions and institute appropriate medical care.

Laboratory Test Interference: Platelet Counts

Interference with automated platelet counts (platelet clumping) has been observed following administration of ADAKVEO, in particular, when blood samples were collected in tubes containing EDTA.

Run blood samples within 4 hours of blood collection or collect blood samples in tubes containing citrate. When needed, estimate platelet count via peripheral blood smear.

Pregnancy

Based on animal data ADAKVEO has the potential to cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. ADAKVEO should only be used during pregnancy if the expected benefit to the patient justifies the potential risk to the fetus.

Most Common Adverse Reactions

The most frequently reported adverse reactions (≥10%) in patients treated with ADAKVEO were nausea (18%), arthralgia (18%), back pain (15%), and pyrexia (11%).

Other Clinically Important Adverse Reactions

Clinically relevant adverse reactions (all grades) that were reported in <10% of patients treated with ADAKVEO included: oropharyngeal pain, abdominal pain (abdominal pain, upper abdominal pain, lower abdominal pain, abdominal discomfort, and abdominal tenderness), diarrhea, vomiting, pruritus (pruritus and vulvovaginal pruritus), musculoskeletal chest pain, myalgia, infusion-site reaction (infusion-site extravasation, infusion-site pain, and infusion-site swelling), and infusion-related reaction.

Please see full Prescribing Information at https://www.novartis.us/sites/www.novartis.us/files/adakveo.pdf.

Novartis Pharmaceuticals Corporation

 

 

Novartis Pharmaceuticals Corporation does not guarantee payment of any claim. Coding, coverage, and reimbursement may vary significantly by payer, plan, patient, and setting of care. Actual coverage and reimbursement decisions are made by individual payers following the receipt of claims. For additional information, customers should consult with their payers for all relevant coding, reimbursement, and coverage requirements. It is the sole responsibility of the provider to select the proper code and ensure the accuracy of all claims used in seeking reimbursement. All   services must be medically appropriate and properly supported in the patient medical record.

 

 

Corporate Member Update: Pharmacyclics-IMBRUVICA® + RITUXIMAB vs FCR: Data From a Head-to-Head Trial in 1L CLL/SLL

Imbruvica
June, 2020

Pharmacyclics has an upcoming unique National Broadcast opportunity happening on Wednesday, June 17th to educate practices on Imbruvica’s new FDA approved label update: IMBRUVICA® + RITUXIMAB vs FCR: Data From a Head-to-Head Trial in 1L CLL/SLL . This format provides a unique opportunity for national participation & interaction. For more information regarding the upcoming event, please click on the flyer below!

 

Corporate Member Update: Takeda Oncology-Label expansion for ALUNBRIG®

ALUNBRIG® (brigatinib)
May, 2020

The US Food and Drug Administration (FDA) has approved the label expansion for ALUNBRIG® (brigatinib) to include patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC) who are tyrosine kinase inhibitor (TKI)-naive.

ALUNBRIG is indicated for the treatment of adult patients with ALK+ metastatic NSCLC as detected by an FDA-approved test.

Please click here to review more information on ALUNBRIG.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Interstitial Lung Disease (ILD)/Pneumonitis: Severe, life-threatening, and fatal pulmonary adverse reactions consistent with interstitial lung disease (ILD)/pneumonitis have occurred with ALUNBRIG. In the ALUNBRIG arm of trial ALTA 1L (180 mg once daily), ILD/pneumonitis occurred in 5.1% of patients receiving ALUNBRIG. ILD/pneumonitis occurred within 8 days of initiation of ALUNBRIG in 2.9% of patients, with Grade 3 to 4 reactions occurring in 2.2% of patients. In Trial ALTA, ILD/pneumonitis occurred in 3.7% of patients in the 90 mg group (90 mg once daily) and 9.1% of patients in the 90→180 mg group (180 mg once daily with 7-day lead-in at 90 mg once daily). Adverse reactions consistent with possible ILD/pneumonitis occurred early within 9 days of initiation of ALUNBRIG (median onset was 2 days) in 6.4% of patients, with Grade 3 to 4 reactions occurring in 2.7%. Monitor for new or worsening respiratory symptoms (e.g., dyspnea, cough, etc.), particularly during the first week of initiating ALUNBRIG. Withhold ALUNBRIG in any patient with new or worsening respiratory symptoms, and promptly evaluate for ILD/pneumonitis or other causes of respiratory symptoms (e.g., pulmonary embolism, tumor progression, and infectious pneumonia). For Grade 1 or 2 ILD/pneumonitis, either resume ALUNBRIG with dose reduction after recovery to baseline or permanently discontinue ALUNBRIG. Permanently discontinue ALUNBRIG for Grade 3 or 4 ILD/pneumonitis or recurrence of Grade 1 or 2 ILD/pneumonitis.

Hypertension: In the ALUNBRIG arm of trial ALTA 1L (180 mg once daily), hypertension was reported in 32% of patients receiving ALUNBRIG; Grade 3 hypertension occurred in 13% of patients. In ALTA, hypertension was reported in 11% of patients in the 90 mg group who received ALUNBRIG and 21% of patients in the 90→180 mg group. Grade 3 hypertension occurred in 5.9% of patients overall. Control blood pressure prior to treatment with ALUNBRIG. Monitor blood pressure after 2 weeks and at least monthly thereafter during treatment with ALUNBRIG. Withhold ALUNBRIG for Grade 3 hypertension despite optimal antihypertensive therapy. Upon resolution or improvement to Grade 1, resume ALUNBRIG at the same dose. Consider permanent discontinuation of treatment with ALUNBRIG for Grade 4 hypertension or recurrence of Grade 3 hypertension. Use caution when administering ALUNBRIG in combination with antihypertensive agents that cause bradycardia.

Bradycardia: In the ALUNBRIG arm of trial ALTA 1L (180 mg once daily), heart rates less than 50 beats per minute (bpm) occurred in 8.1% of patients receiving ALUNBRIG. Grade 3 bradycardia occurred in 1 patient (0.7%). In ALTA, heart rates less than 50 beats per minute (bpm) occurred in 5.7% of patients in the 90 mg group and 7.6% of patients in the 90→180 mg group. Grade 2 bradycardia occurred in 1 (0.9%) patient in the 90 mg group. Monitor heart rate and blood pressure during treatment with ALUNBRIG. Monitor patients more frequently if concomitant use of drug known to cause bradycardia cannot be avoided. For symptomatic bradycardia, withhold ALUNBRIG and review concomitant medications for those known to cause bradycardia. If a concomitant medication known to cause bradycardia is identified and discontinued or dose adjusted, resume ALUNBRIG at the same dose following resolution of symptomatic bradycardia; otherwise, reduce the dose of ALUNBRIG following resolution of symptomatic bradycardia. Discontinue ALUNBRIG for
life-threatening bradycardia if no contributing concomitant medication is identified.

Visual Disturbance: In the ALUNBRIG arm of trial ALTA 1L (180 mg once daily), Grade 1 or 2 adverse reactions leading to visual disturbance including blurred vision, photophobia, photopsia, and reduced visual acuity were reported in 7.4% of patients receiving ALUNBRIG. In ALTA, adverse reactions leading to visual disturbance including blurred vision, diplopia, and reduced visual acuity, were reported in 7.3% of patients treated with ALUNBRIG in the 90 mg group and 10% of patients in the 90→180 mg group. Grade 3 macular edema and cataract occurred in one patient each in the 90→180 mg group. Advise patients to report any visual symptoms. Withhold ALUNBRIG and obtain an ophthalmologic evaluation in patients with new or worsening visual symptoms of Grade 2 or greater severity. Upon recovery of Grade 2 or Grade 3 visual disturbances to Grade 1 severity or baseline, resume ALUNBRIG at a reduced dose. Permanently discontinue treatment with ALUNBRIG for Grade 4 visual disturbances.

Creatine Phosphokinase (CPK) Elevation: In the ALUNBRIG arm of trial ALTA 1L (180 mg once daily), creatine phosphokinase (CPK) elevation occurred in 81% of patients who received ALUNBRIG. The incidence of Grade 3 or 4 CPK elevation was 24%. Dose reduction for CPK elevation occurred in 15% of patients. In ALTA, CPK elevation occurred in 27% of patients receiving ALUNBRIG in the 90 mg group and 48% of patients in the 90 mg→180 mg group. The incidence of Grade 3-4 CPK elevation was 2.8% in the 90 mg group and 12% in the 90→180 mg group. Dose reduction for CPK elevation occurred in 1.8% of patients in the 90 mg group and 4.5% in the 90→180 mg group. Advise patients to report any unexplained muscle pain, tenderness, or weakness. Monitor CPK levels during ALUNBRIG treatment. Withhold ALUNBRIG for Grade 3 or 4 CPK elevation with Grade 2 or higher muscle pain or weakness. Upon resolution or recovery to Grade 1 CPK elevation or baseline, resume ALUNBRIG at the same dose or at a reduced dose.

Pancreatic Enzyme Elevation: In the ALUNBRIG arm of trial ALTA 1L (180 mg once daily), amylase elevation occurred in 52% of patients and Grade 3 or 4 amylase elevation occurred in 6.8% of patients. Lipase elevations occurred in 59% of patients and Grade 3 or 4 lipase elevation occurred in 17% of patients. In ALTA, amylase elevation occurred in 27% of patients in the 90 mg group and 39% of patients in the 90→180 mg group. Lipase elevations occurred in 21% of patients in the 90 mg group and 45% of patients in the 90→180 mg group. Grade 3 or 4 amylase elevation occurred in 3.7% of patients in the 90 mg group and 2.7% of patients in the
90→180 mg group. Grade 3 or 4 lipase elevation occurred in 4.6% of patients in the 90 mg group and 5.5% of patients in the 90→180 mg group. Monitor lipase and amylase during treatment with ALUNBRIG. Withhold ALUNBRIG for Grade 3 or 4 pancreatic enzyme elevation. Upon resolution or recovery to Grade 1 or baseline, resume ALUNBRIG at the same dose or at a reduced dose.

Hyperglycemia: In the ALUNBRIG arm of trial ALTA 1L (180 mg once daily), 56% of patients who received ALUNBRIG experienced new or worsening hyperglycemia. Grade 3 hyperglycemia, based on laboratory assessment of serum fasting glucose levels, occurred in 7.5% of patients. In ALTA, 43% of patients who received ALUNBRIG experienced new or worsening hyperglycemia. Grade 3 hyperglycemia, based on laboratory assessment of serum fasting glucose levels, occurred in 3.7% of patients. Two of 20 (10%) patients with diabetes or glucose intolerance at baseline required initiation of insulin while receiving ALUNBRIG. Assess fasting serum glucose prior to initiation of ALUNBRIG and monitor periodically thereafter. Initiate or optimize anti-hyperglycemic medications as needed. If adequate hyperglycemic control cannot be achieved with optimal medical management, withhold ALUNBRIG until adequate hyperglycemic control is achieved and consider reducing the dose of ALUNBRIG or permanently discontinuing ALUNBRIG.

Embryo-Fetal Toxicity: Based on its mechanism of action and findings in animals, ALUNBRIG can cause fetal harm when administered to pregnant women. There are no clinical data on the use of ALUNBRIG in pregnant women. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective non-hormonal contraception during treatment with ALUNBRIG and for at least 4 months following the final dose. Advise males with female partners of reproductive potential to use effective contraception during treatment and for at least 3 months after the last dose of ALUNBRIG.

ADVERSE REACTIONS

In ALTA 1L, serious adverse reactions occurred in 33% of patients receiving ALUNBRIG. The most common serious adverse reactions were pneumonia (4.4%), ILD/pneumonitis (3.7%), pyrexia (2.9%), dyspnea (2.2%), pulmonary embolism (2.2%), and asthenia (2.2%). Fatal adverse reactions occurred in 2.9% of patients and included pneumonia (1.5%), cerebrovascular accident (0.7%), and multiple organ dysfunction syndrome (0.7%).

In ALTA, serious adverse reactions occurred in 38% of patients in the 90 mg group and 40% of patients in the 90→180 mg group. The most common serious adverse reactions were pneumonia (5.5% overall, 3.7% in the 90 mg group, and 7.3% in the 90→180 mg group) and ILD/pneumonitis (4.6% overall, 1.8% in the 90 mg group and 7.3% in the 90→180 mg group). Fatal adverse reactions occurred in 3.7% of patients and consisted of pneumonia (2 patients), sudden death, dyspnea, respiratory failure, pulmonary embolism, bacterial meningitis and urosepsis (1 patient each).

The most common adverse reactions (≥25%) with ALUNBRIG were diarrhea (49%), fatigue (39%), nausea (39%), rash (38%), cough (37%), myalgia (34%), headache (31%), hypertension (31%), vomiting (27%), and dyspnea (26%).

DRUG INTERACTIONS

CYP3A Inhibitors: Avoid coadministration of ALUNBRIG with strong or moderate CYP3A inhibitors. Avoid grapefruit or grapefruit juice as it may also increase plasma concentrations of brigatinib. If coadministration of a strong or moderate CYP3A inhibitor cannot be avoided, reduce the dose of ALUNBRIG.

CYP3A Inducers: Avoid coadministration of ALUNBRIG with strong or moderate CYP3A inducers. If coadministration of moderate CYP3A inducers cannot be avoided, increase the dose of ALUNBRIG

CYP3A Substrates: Coadministration of ALUNBRIG with sensitive CYP3A substrates, including hormonal contraceptives, can result in decreased concentrations and loss of efficacy of sensitive CYP3A substrates.

USE IN SPECIFIC POPULATIONS

Pregnancy: ALUNBRIG can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus.

Lactation: There are no data regarding the secretion of brigatinib in human milk or its effects on the breastfed infant or milk production. Because of the potential adverse reactions in breastfed infants, advise lactating women not to breastfeed during treatment with ALUNBRIG.

Females and Males of Reproductive Potential:

Pregnancy Testing: Verify pregnancy status in females of reproductive potential prior to initiating ALUNBRIG

Contraception: Advise females of reproductive potential to use effective
non-hormonal contraception during treatment with ALUNBRIG and for at least 4 months after the final dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with ALUNBRIG and for at least 3 months after the final dose.

Infertility: ALUNBRIG may cause reduced fertility in males.

Pediatric Use: The safety and effectiveness of ALUNBRIG in pediatric patients have not been established.

Geriatric Use: Of the 359 patients enrolled in the ALTA 1L ALUNBRIG arm and in ALTA, 26.7% were 65 and older and 7.5% were 75 and older. No clinically relevant differences in safety or efficacy were observed between patients ≥65 years and younger patients.

Hepatic or Renal Impairment: No dose adjustment is recommended for patients with mild or moderate hepatic impairment or mild or moderate renal impairment. Reduce the dose of ALUNBRIG for patients with severe hepatic impairment or severe renal impairment.

Please click the link for ALUNBRIG full Prescribing Information.

Corporate Member Update: Merck’s Response to Coronavirus (COVID-19)

May, 2020

During this unprecedented time, Merck is committed to ensuring our medicines and vaccines reach our patients and customers. This includes supporting patients who might need more help today with their medications, including those who are unemployed or have lost insurance coverage due to the COVID-19 pandemic. To learn about what support options may be available, visit our Access and Patient Assistance information page.

For more details about Merck’s response to coronavirus, visit our COVID-19 information page.

New FDA Approval: Rubraca

Rubraca
May, 2020

Clovis Oncology has some exciting new to share! On May 15, 2020, the FDA approved Rubraca (rucaparib) for a new indication. To learn more, please follow the link here. You can also find the full prescribing information here.

Corporate Member Update: Takeda Oncoly Patient Support Program

May, 2020

Takeda Oncology has changed the name of their patient support program from Takeda Oncology 1Point to Takeda Oncology Here2Assist™ effective May 18, 2020. Please note that only the name is changing. Patients and providers will continue to have the same high level of comprehensive, personalized support. Please review this information for important details.

Corporate Member Update-Lilly: New FDA Approval for Retevmo™

May, 2020

Lilly USA, LLC is pleased to announce that the US Food and Drug Administration (FDA) has approved Retevmo™ (selpercatinib, 80-mg and 40-mg capsules) on May 08, 2020 for the treatment of:

Adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC)
Adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy
Adult and pediatric patients 12 years of age and older with advanced or metastatic

RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate)

These indications are approved under accelerated approval based on objective response rate (ORR) and duration of response (DoR). Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.>

Retevmo is now available for ordering, and shipping is anticipated to begin on or after the week of May 11, 2020.

I look forward to scheduling time to review the clinical information associated with this

newly approved treatment option for patients with certain RET-driven cancers.

Please see Important Safety Information below and click for full Prescribing Information for Retevmo.

IMPORTANT SAFETY INFORMATION

Corporate Member Merck- Update

KEYTRUDA
May, 2019

Merck is pleased to announce that KEYTRUDA, in combination with axitinib, has been approved by the FDA for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

PD-L1 diagnostic testing is not required prior to initiating treatment with KEYTRUDA in these patients

FDA=Food and Drug Administration; PD-L1=programmed death ligand 1.

Selected Safety Information for KEYTRUDA® (pembrolizumab) injection 100 mg

Immune-mediated adverse reactions, which may be severe or fatal, can occur with KEYTRUDA, including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, severe skin reactions, solid organ transplant rejection, and complications of allogeneic hematopoietic stem cell transplantation (HSCT). Based on the severity of the adverse reaction, KEYTRUDA should be withheld or discontinued and corticosteroids administered if appropriate. For more information regarding immune-mediated adverse reactions, please read the additional Selected Safety Information below.

KEYNOTE-426
First-line Treatment of Advanced RCC in Combination With Axitinib

The efficacy of KEYTRUDA in combination with axitinib was investigated in KEYNOTE-426 (NCT02853331), a randomized, multicenter, open-label trial conducted in 861 patients who had not received systemic therapy for advanced RCC. Patients were enrolled regardless of PD-L1 tumor expression status. Patients with active autoimmune disease requiring systemic immunosuppression within the last 2 years were ineligible. Randomization was stratified by International Metastatic RCC Database Consortium (IMDC) risk categories (favorable versus intermediate versus poor) and geographic region (North America versus Western Europe versus “Rest of the World”).

Patients were randomized (1:1) to one of the following treatment arms:

KEYTRUDA 200 mg intravenously every 3 weeks up to 24 months in combination with axitinib 5 mg orally, twice daily. Patients who tolerated axitinib 5 mg twice daily for 2 consecutive cycles (6 weeks) could increase to 7 mg and then subsequently to 10 mg twice daily. Axitinib could be interrupted or reduced to 3 mg twice daily and subsequently to 2 mg twice daily to manage toxicity.
Sunitinib 50 mg orally, once daily for 4 weeks and then off treatment for 2 weeks.

Treatment with KEYTRUDA and axitinib continued until Response Evaluation Criteria in Solid Tumors (RECIST) v1.1-defined progression of disease or unacceptable toxicity. Administration of KEYTRUDA and axitinib was permitted beyond RECIST-defined disease progression if the patient was clinically stable and considered to be deriving clinical benefit by the investigator. Assessment of tumor status was performed at baseline, after randomization at Week 12, then every 6 weeks thereafter until Week 54, and then every 12 weeks thereafter.

The study population characteristics were: median age of 62 years (range: 26 to 90); 38% age 65 or older; 73% male; 79% White and 16% Asian; 19% and 80% of patients had a baseline Karnofsky Performance Scale (KPS) of 70 to 80 and 90 to 100, respectively; and patient distribution by IMDC risk categories was 31% favorable, 56% intermediate and 13% poor.

The main efficacy outcome measures were overall survival (OS) and progression-free survival (PFS) as assessed by blinded independent central review (BICR) according to modified RECIST v1.1. Additional efficacy outcome measures included overall response rate (ORR), as assessed by BICR. A statistically significant improvement in OS was demonstrated at the pre-specified interim analysis in patients randomized to KEYTRUDA in combination with axitinib compared with sunitinib. The trial also demonstrated statistically significant improvement in PFS and ORR. The table below summarizes the efficacy results for KEYNOTE-426. The median follow-up time was 12.8 months (range 0.1 to 22.0 months). Consistent results were observed across pre-specified subgroups, IMDC risk categories and PD-L1 tumor expression status.

Efficacy Results in KEYNOTE-426

Endpoint

KEYTRUDA
with axitinib
n=432

Sunitinib
n=429

OS

Number of patients with event (%)

59 (14%)

97 (23%)

Median in months (95% CI)

NR (NR, NR)

NR (NR, NR)

Hazard ratio* (95% CI)

0.53 (0.38, 0.74)

p-Value†

<0.0001‡

12-month OS rate

90% (86, 92)

78% (74, 82)

PFS

 

Number of patients with event (%)

183 (42%)

212 (49%)

Median in months (95% CI)

15.1 (12.6, 17.7)

11.1 (8.7, 12.5)

Hazard ratio* (95% CI)

0.69 (0.57, 0.84)

p-Value†

0.0001§

ORR

Overall confirmed response rate
(95% CI)

59% (54, 64)

36% (31, 40)

Complete response

6%

2%

Partial response

53%

34%

p-Value¶

<0.0001

*Based on the stratified Cox proportional hazard model

†Based on stratified log-rank test

‡p-Value (one-sided) is compared with the allocated alpha of 0.0001 for this interim analysis (with 39% of the planned number of events for final analysis).

§p-Value (one-sided) is compared with the allocated alpha of 0.0013 for this interim analysis (with 81% of the planned number of events for final analysis).

¶Based on Miettinen and Nurminen method stratified by IMDC risk group and geographic region

NR=not reached

CI=confidence interval.

Recommended Dosage for RCC

The recommended dose of KEYTRUDA is 200 mg administered as an intravenous infusion over 30 minutes every 3 weeks in combination with 5 mg axitinib orally twice daily until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months in patients without disease progression. When axitinib is used in combination with KEYTRUDA, dose escalation of axitinib above the initial 5 mg dose may be considered at intervals of six weeks or longer. See also the Prescribing Information for recommended axitinib dosing information.

Selected Safety Information for KEYTRUDA® (pembrolizumab) injection 100 mg (continued)

Immune-Mediated Pneumonitis

KEYTRUDA can cause immune-mediated pneumonitis, including fatal cases. Pneumonitis occurred in 3.4% (94/2799) of patients receiving KEYTRUDA, including Grade 1 (0.8%), 2 (1.3%), 3 (0.9%), 4 (0.3%), and 5 (0.1%), and occurred more frequently in patients with a history of prior thoracic radiation (6.9%) compared to those without (2.9%). Monitor patients for signs and symptoms of pneumonitis. Evaluate suspected pneumonitis with radiographic imaging. Administer corticosteroids for Grade 2 or greater pneumonitis. Withhold KEYTRUDA for Grade 2; permanently discontinue KEYTRUDA for Grade 3 or 4 or recurrent Grade 2 pneumonitis.

Immune-Mediated Colitis

KEYTRUDA can cause immune-mediated colitis. Colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 2 (0.4%), 3 (1.1%), and 4 (<0.1%). Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 or greater colitis. Withhold KEYTRUDA for Grade 2 or 3; permanently discontinue KEYTRUDA for Grade 4 colitis.

Immune-Mediated Hepatitis, or Hepatotoxicity (in Combination With Axitinib)

Immune-Mediated Hepatitis

KEYTRUDA can cause immune-mediated hepatitis. Hepatitis occurred in 0.7% (19/2799) of patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.4%), and 4 (<0.1%). Monitor patients for changes in liver function. Administer corticosteroids for Grade 2 or greater hepatitis and, based on severity of liver enzyme elevations, withhold or discontinue KEYTRUDA.

Hepatotoxicity (in Combination With Axitinib)

KEYTRUDA in combination with axitinib can cause hepatic toxicity with higher than expected frequencies of Grades 3 and 4 alanine aminotransferase (ALT) and aspartate aminotransferase (AST) elevations compared to KEYTRUDA alone. Grades 3 and 4 increased ALT and AST were seen in 20% and 13% of patients, respectively. Monitor liver enzymes before initiation of and periodically throughout treatment. Consider more frequent monitoring of liver enzymes as compared to when the drugs are used in monotherapy. For elevated liver enzymes, interrupt KEYTRUDA and axitinib, and consider administering corticosteroids as needed.

Immune-Mediated Endocrinopathies

KEYTRUDA can cause hypophysitis, thyroid disorders, and type 1 diabetes mellitus. Hypophysitis occurred in 0.6% (17/2799) of patients, including Grade 2 (0.2%), 3 (0.3%), and 4 (<0.1%). Hypothyroidism occurred in 8.5% (237/2799) of patients, including Grade 2 (6.2%) and 3 (0.1%). Hyperthyroidism occurred in 3.4% (96/2799) of patients, including Grade 2 (0.8%) and 3 (0.1%), and thyroiditis occurred in 0.6% (16/2799) of patients, including Grade 2 (0.3%). Type 1 diabetes mellitus, including diabetic ketoacidosis, occurred in 0.2% (6/2799) of patients.
Monitor patients for signs and symptoms of hypophysitis (including hypopituitarism and adrenal insufficiency), thyroid function (prior to and periodically during treatment), and hyperglycemia. For hypophysitis, administer corticosteroids and hormone replacement as clinically indicated. Withhold KEYTRUDA for Grade 2 and withhold or discontinue for Grade 3 or 4 hypophysitis. Administer hormone replacement for hypothyroidism and manage hyperthyroidism with thionamides and beta-blockers as appropriate. Withhold or discontinue KEYTRUDA for Grade 3 or 4 hyperthyroidism. Administer insulin for type 1 diabetes and withhold KEYTRUDA and administer antihyperglycemics in patients with severe hyperglycemia.

Immune-Mediated Nephritis and Renal Dysfunction

KEYTRUDA can cause immune-mediated nephritis. Nephritis occurred in 0.3% (9/2799) of patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.1%), and 4 (<0.1%) nephritis. Monitor patients for changes in renal function. Administer corticosteroids for Grade 2 or greater nephritis. Withhold KEYTRUDA for Grade 2; permanently discontinue for Grade 3 or 4 nephritis.

Immune-Mediated Skin Reactions

Immune-mediated rashes, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) (some cases with fatal outcome), exfoliative dermatitis, and bullous pemphigoid, can occur. Monitor patients for suspected severe skin reactions and based on the severity of the adverse reaction, withhold or permanently discontinue KEYTRUDA and administer corticosteroids. For signs or symptoms of SJS or TEN, withhold KEYTRUDA and refer the patient for specialized care for assessment and treatment. If SJS or TEN is confirmed, permanently discontinue KEYTRUDA.

Other Immune-Mediated Adverse Reactions

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue in patients receiving KEYTRUDA and may also occur after discontinuation of treatment. For suspected immune-mediated adverse reactions, ensure adequate evaluation to confirm etiology or exclude other causes. Based on the severity of the adverse reaction, withhold KEYTRUDA and administer corticosteroids. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Based on limited data from clinical studies in patients whose immune-related adverse reactions could not be controlled with corticosteroid use, administration of other systemic immunosuppressants can be considered. Resume KEYTRUDA when the adverse reaction remains at Grade 1 or less following corticosteroid taper. Permanently discontinue KEYTRUDA for any Grade 3 immune-mediated adverse reaction that recurs and for any life-threatening immune-mediated adverse reaction.
The following clinically significant immune-mediated adverse reactions occurred in less than 1% (unless otherwise indicated) of 2799 patients: arthritis (1.5%), uveitis, myositis, Guillain-Barré syndrome, myasthenia gravis, vasculitis, pancreatitis, hemolytic anemia, sarcoidosis, and encephalitis. In addition, myelitis and myocarditis were reported in other clinical trials, including classical Hodgkin lymphoma, and postmarketing use.
Treatment with KEYTRUDA may increase the risk of rejection in solid organ transplant recipients. Consider the benefit of treatment vs the risk of possible organ rejection in these patients.

Infusion-Related Reactions

KEYTRUDA can cause severe or life-threatening infusion-related reactions, including hypersensitivity and anaphylaxis, which have been reported in 0.2% (6/2799) of patients. Monitor patients for signs and symptoms of infusion-related reactions. For Grade 3 or 4 reactions, stop infusion and permanently discontinue KEYTRUDA.

Complications of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

Immune-mediated complications, including fatal events, occurred in patients who underwent allogeneic HSCT after treatment with KEYTRUDA. Follow patients closely for early evidence of transplant-related complications such as hyperacute graft-versus-host disease (GVHD), Grade 3 to 4 acute GVHD, steroid-requiring febrile syndrome, hepatic veno-occlusive disease (VOD), and other immune-mediated adverse reactions.
In patients with a history of allogeneic HSCT, acute GVHD (including fatal GVHD) has been reported after treatment with KEYTRUDA. Patients who experienced GVHD after their transplant procedure may be at increased risk for GVHD after KEYTRUDA. Consider the benefit of KEYTRUDA vs the risk of GVHD in these patients.

Increased Mortality in Patients With Multiple Myeloma

In trials in patients with multiple myeloma, the addition of KEYTRUDA to a thalidomide analogue plus dexamethasone resulted in increased mortality. Treatment of these patients with a programmed death receptor-1 (PD-1) or PD-L1 blocking antibody in this combination is not recommended outside of controlled trials.

Embryofetal Toxicity

Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. Advise women of this potential risk. In females of reproductive potential, verify pregnancy status prior to initiating KEYTRUDA and advise them to use effective contraception during treatment and for 4 months after the last dose.

Adverse Reactions

In KEYNOTE-426, when KEYTRUDA was administered in combination with axitinib, fatal adverse reactions occurred in 3.3% of 429 patients. Serious adverse reactions occurred in 40% of patients, the most frequent (≥1%) were hepatotoxicity (7%), diarrhea (4.2%), acute kidney injury (2.3%), dehydration (1%), and pneumonitis (1%). Permanent discontinuation due to an adverse reaction occurred in 31% of patients; KEYTRUDA only (13%), axitinib only (13%), and the combination (8%); the most common were hepatotoxicity (13%), diarrhea/colitis (1.9%), acute kidney injury (1.6%), and cerebrovascular accident (1.2%). The most common adverse reactions (≥20%) were diarrhea (56%), fatigue/asthenia (52%), hypertension (48%), hepatotoxicity (39%), hypothyroidism (35%), decreased appetite (30%), palmar-plantar erythrodysesthesia (28%), nausea (28%), stomatitis/mucosal inflammation (27%), dysphonia (25%), rash (25%), cough (21%), and constipation (21%).

Lactation

Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment and for 4 months after the final dose.

Before prescribing KEYTRUDA® (pembrolizumab), please read the Prescribing Information.
The Medication Guide also is available.

Corporate Member Update: Novartis-FDA approval of TABRECTA™ (capmatinib)

TABRECTA
May, 2020

TABRECTA tablets is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test.

This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

FoundationOne®CDx is the FDA-approved companion diagnostic test for TABRECTA.

I would like to share the clinical safety and efficacy information associated with TABRECTA. I will contact you to continue our discussions about TABRECTA as a treatment option.

Important Safety Information

Interstitial Lung Disease (ILD)/Pneumonitis. ILD/pneumonitis, which can be fatal, occurred in patients treated with TABRECTA. ILD/pneumonitis occurred in 4.5% of patients treated with TABRECTA in the GEOMETRY mono-1 study, with 1.8% of patients experiencing grade 3 ILD/pneumonitis and 1 patient experiencing death (0.3%). Eight patients (2.4%) discontinued TABRECTA due to ILD/pneumonitis.

Monitor for new or worsening pulmonary symptoms indicative of ILD/pneumonitis (eg, dyspnea, cough, fever). Immediately withhold TABRECTA in patients with suspected ILD/pneumonitis and permanently discontinue if no other potential causes of ILD/pneumonitis are identified.

Hepatotoxicity. Hepatotoxicity occurred in patients treated with TABRECTA. Increased alanine aminotransferase (ALT)/aspartate aminotransferase (AST) occurred in 13% of patients treated with TABRECTA in GEOMETRY mono-1. Grade 3 or 4 increased ALT/AST occurred in 6% of patients. Three patients (0.9%) discontinued TABRECTA due to increased ALT/AST.

Monitor liver function tests (including ALT, AST, and total bilirubin) prior to the start of TABRECTA, every 2 weeks during the first 3 months of treatment, then once a month or as clinically indicated, with more frequent testing in patients who develop increased transaminases or bilirubin. Based on the severity of the adverse reaction, withhold, reduce dose, or permanently discontinue TABRECTA.

Risk of Photosensitivity. Based on findings from animal studies, there is a potential risk of photosensitivity reactions with TABRECTA. In GEOMETRY mono-1, it was recommended that patients use precautionary measures against ultraviolet exposure, such as use of sunscreen or protective clothing, during treatment with TABRECTA. Advise patients to limit direct ultraviolet exposure during treatment with TABRECTA.

Embryo-Fetal Toxicity. Based on findings from animal studies and its mechanism of action, TABRECTA can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with TABRECTA and for 1 week after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with TABRECTA and for 1 week after the last dose.

Most Common Adverse Reactions. The most common adverse reactions (≥20%) were peripheral edema (52%), nausea (44%), fatigue (32%), vomiting (28%), dyspnea (24%), and decreased appetite (21%). The most common grade 3 adverse reactions (≥2%) were peripheral edema (9%), fatigue (8%), dyspnea (7%), nausea (2.7%), vomiting (2.4%), and noncardiac chest pain (2.1%). 

Clinically Relevant Adverse Reactions. Clinically relevant adverse reactions observed in <10% of patients were pruritus (allergic and generalized), ILD/pneumonitis, cellulitis, acute kidney injury (including renal failure), urticaria, and acute pancreatitis.

Laboratory Abnormalities. Select laboratory abnormalities (≥20%) worsening from baseline in patients who received TABRECTA were decreased albumin (68%), increased creatinine (62%), decreased lymphocytes (44%), increased ALT (37%), increased alkaline phosphatase (32%), increased amylase (31%), increased gamma-glutamyltransferase (29%), increased lipase (26%), increased AST (25%), decreased hemoglobin (24%), decreased leukocytes (23%), decreased sodium (23%), decreased phosphate (23%), increased potassium (23%), and decreased glucose (21%).

 

Click here for the official press release!

New FDA Approval: Immunomedics

Trodelvy
May, 2020

Immunomedics is proud to announce that the U.S. Food and Drug Administration (FDA) has approved Trodelvy™ (sacituzumab govitecan-hziy)for the treatment of adult patients with metastatic triple-negative breast cancer (TNBC)who have received at least two prior therapies for metastatic disease.Trodelvyis the first ADC approved bytheFDAspecifically for relapsedor refractorymetastatic TNBCand is also the first FDA-approved anti-Trop-2 ADC.

To read the full announcement, please click this link.

Corporate Member Update: Seattle Genetics

TUKYSA
May, 2020

Seattle Genetics is excited to announce the approval of TUKYSA by the U.S. Food and Drug Administration (FDA). TUKYSA is indicated in combination with trastuzumab and capecitabine for treatment of adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting.

To read the full announcement and important safety information, please click here!

Corporate Member Update: Merck Keytruda Update

Keytruda
May, 2020

Corporate member Merck has updated dosing information (in sections 1.16 and 2.2) for KEYTRUDA® (pembrolizumab) Injection 100 mg. To read these updates, please visit this link.

Corporate Member Update: Takeda Oncology Support During COVID-19

April, 2020

In response to COVID-19 and during this period of uncertainty, Takeda Oncology will maintain engagement and continued support. A top priority of Takeda Oncology remains ensuring continuity of care for your patients and ensuring they receive medicines required for treatment. Like you, we are committed to doing what we can to help protect patients, healthcare professionals and the stakeholders we serve.
 
Please be assured that we do not currently anticipate any delays in being able to deliver our oncology medicines to patients and will continue to closely monitor the situation at it evolves. We have also been in touch with specialty pharmacies in our network and confirmed their ability to supply medications to patients.
 
I also want to take the opportunity to remind you of Takeda’s patient support services program, Takeda Oncology 1Point, which is a comprehensive program committed to helping patients taking Takeda Oncology medicines navigate coverage requirements, identify available financial assistance and connect with helpful resources throughout their treatment. The Takeda Oncology 1Point Patient Support Program has well-established contingency plans should the need arise. Any customer questions should be directed to Takeda Oncology 1Point at 1-844-817-6468, Option 2. To assist your patients in enrolling in Takeda Oncology 1Point, please download the enrollment form at Takedaoncology1point.com.

As part of Takeda Oncology 1Point’s financial assistance offerings, there are two programs that may be able to help your patients with the cost of their treatment:
     •    For patients who are commercially insured and concerned about their out-of-pocket costs, the Takeda Oncology Co-Pay Assistance Program* may be able to help

     •    For patients who are uninsured, or the prescribed medication is not covered, the Takeda Oncology Patient Assistance Program (PAP)† may be able to provide eligible patients with a monthly supply of medication at no cost to them.

In addition to the financial assistance programs, Takeda Oncology 1Point case managers can provide patients with information about additional resources that may assist with the day-to-day support they need, including:
     •    Assistance with treatment-related expenses (transportation support, legal services, etc.)

     •    Education about their treatment

     •    Connections to local and national advocacy groups

     •    Access to counseling or emotional support

     •    Information regarding open foundational support programs which may be able to assist with treatment costs

You may contact the Takeda Oncology 1Point patient support service line at 844-817-6468 for product related questions.

Corporate Member Update: Merck Product Launch

ONTRUZANT®
April, 2020

Merck Sharp & Dohme Corp. (“Merck”), a subsidiary of Merck & Co., Inc., is pleased to announce that ONTRUZANT® (trastuzumab-dttb) for injection, for intravenous use 21 mg/mL, a biosimilar* to Herceptin® (trastuzumab), is available through specialty distributors and wholesalers. Please contact your specialty distributor or wholesaler to confirm product availability.

*Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the biosimilar product and the reference product. Biosimilarity of ONTRUZANT has been demonstrated for the condition(s) of use (eg, indication(s), dosing regimen(s), strength(s), dosage form(s), and route(s) of administration described in its Full Prescribing Information).

ONTRUZANT is available as follows:

PRODUCT

HCPCS CODE1 DESCRIPTOR1

HOW

SUPPLIED
NDC

CATALOG

PRICEa
ONTRUZANT

Q5112

Injection,

trastuzumab-dttb,

biosimilar (ONTRUZANT),

 mg

Carton with one

150-mg vial,

single-dose

----------------
Carton with one

420-mg vial,

multi-dose

 

0006-5033-02

 

----------

0006-5034-02
 

 

$1,324.66
 

--

 

$3,709.04

 

HCPCS, Healthcare Common Procedure Coding System; NDC, National Drug Code.

aMerck catalog price as of March 2020; subject to change without notice. Catalog price does not necessarily reflect the actual price paid by consumers, payers, or dispensers.

The information provided here is compiled from sources believed to be accurate, but Merck makes no representation that it is accurate. Information about Healthcare Common Procedure Coding System (HCPCS) codes is based on guidance issued by the Centers for Medicare & Medicaid Services (CMS) applicable to Medicare Part B and may not apply to other public or private payers. Consult the relevant manual and/or other guidelines for a description of each code to determine the appropriateness of a particular code and for information on additional codes. This information is subject to change. Merck cautions that payer coding requirements vary and can frequently change, so it is important to regularly check with each payer or, where applicable, the Medicare Administrative Contractor, as to payer-specific requirements.

Always verify the payer’s coding requirements prior to submitting a claim. Miscellaneous codes such as “not otherwise classified” (J9999) or “unclassified biologics” (J3590) may be used in situations where a payer may have different coding requirements.2

Brands mentioned are the trademarks of their respective owners

 

INDICATIONS AND USAGE

Adjuvant Breast Cancer

ONTRUZANT is indicated for adjuvant treatment of HER2-overexpressing node-positive or node-negative (ER/PR-negative or with one high-risk feature) breast cancer:

  • As part of a treatment regimen containing doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel
  • With docetaxel and carboplatin
  • As a single agent following multimodality anthracycline-based therapy

Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product.

Metastatic Breast Cancer

ONTRUZANT is indicated:

  • In combination with paclitaxel for the first-line treatment of HER2-overexpressing metastatic breast cancer
  • As a single agent for treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease

Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product.

Metastatic Gastric Cancer

ONTRUZANT is indicated, in combination with cisplatin and capecitabine or 5-fluorouracil, for the treatment of patients with HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma who have not received prior treatment for metastatic disease.

Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product.

SELECTED SAFETY INFORMATION

CARDIOMYOPATHY

  • Administration of trastuzumab products can result in subclinical and clinical cardiac failure. The incidence and severity was highest in patients receiving a trastuzumab product with anthracycline-containing chemotherapy regimens. In a pivotal adjuvant breast cancer trial, one patient who developed congestive heart failure (CHF) died of cardiomyopathy.
  • Evaluate left ventricular function in all patients prior to and during treatment with ONTRUZANT. Discontinue ONTRUZANT treatment in patients receiving adjuvant therapy and withhold ONTRUZANT in patients with metastatic disease for clinically significant decrease in left ventricular function.

INFUSION REACTIONS; PULMONARY TOXICITY

  • Administration of trastuzumab products can result in serious and fatal infusion reactions and pulmonary toxicity. Symptoms usually occur during or within 24 hours of administration. Interrupt ONTRUZANT infusion for dyspnea or clinically significant hypotension. Monitor patients until symptoms completely resolve. Discontinue ONTRUZANT for anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome.

EMBRYO-FETAL TOXICITY

  • Exposure to trastuzumab products during pregnancy can result in oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death. Advise patients of these risks and the need for effective contraception.

WARNINGS AND PRECAUTIONS

CARDIOMYOPATHY

Trastuzumab products can cause left ventricular cardiac dysfunction, arrhythmias, hypertension, disabling cardiac failure, cardiomyopathy, and cardiac death. Trastuzumab products can also cause asymptomatic decline in left ventricular ejection fraction (LVEF).

There is a 4- to 6-fold increase in the incidence of symptomatic myocardial dysfunction among patients receiving trastuzumab products as a single agent or in combination therapy compared with those not receiving trastuzumab products. The highest absolute incidence occurs when a trastuzumab product is administered with an anthracycline.

Withhold ONTRUZANT for ≥16% absolute decrease in LVEF from pretreatment values or an LVEF value below institutional limits of normal and ≥10% absolute decrease in LVEF from pretreatment values. The safety of continuation or resumption of ONTRUZANT in patients with trastuzumab-product-induced left ventricular cardiac dysfunction has not been studied.

Patients who receive anthracycline after stopping ONTRUZANT may also be at increased risk of cardiac dysfunction.

Cardiac Monitoring: Conduct thorough cardiac assessment, including history, physical examination, and determination of LVEF by echocardiogram or MUGA scan. The following schedule is recommended:

  • Baseline LVEF measurement immediately prior to initiation of ONTRUZANT
  • LVEF measurements every 3 months during and upon completion of ONTRUZANT
  • Repeat LVEF measurement at 4-week intervals if ONTRUZANT is withheld for significant left ventricular cardiac dysfunction.
  • LVEF measurements every 6 months for at least 2 years following completion of ONTRUZANT as a component of adjuvant therapy.

INFUSION REACTIONS

Infusion reactions consist of a symptom complex characterized by fever and chills, and on occasion included nausea, vomiting, pain (in some cases at tumor sites), headache, dizziness, dyspnea, hypotension, rash, and asthenia.

In postmarketing reports, serious and fatal infusion reactions have been reported. Severe reactions, which include bronchospasm, anaphylaxis, angioedema, hypoxia, and severe hypotension were usually reported during or immediately following the initial infusion. However, the onset and clinical course were variable, including progressive worsening, initial improvement followed by clinical deterioration, or delayed post-infusion events with rapid clinical deterioration. For fatal events, death occurred within hours to days following a serious infusion reaction.

Interrupt ONTRUZANT infusion in all patients experiencing dyspnea, clinically significant hypotension, and intervention of medical therapy administered (which may include epinephrine, corticosteroids, diphenhydramine, bronchodilators, and oxygen). Patients should be evaluated and carefully monitored until complete resolution of signs and symptoms. Permanent discontinuation should be strongly considered in all patients with severe infusion reactions.

There are no data regarding the most appropriate method of identification of patients who may safely be retreated with trastuzumab products after experiencing a severe infusion reaction. Prior to resumption of trastuzumab infusion, the majority of patients who experienced a severe infusion reaction were premedicated with antihistamines and/or corticosteroids. While some patients tolerated trastuzumab infusions, others had recurrent severe infusion reactions despite premedications.

EMBRYO-FETAL TOXICITY

Trastuzumab products can cause fetal harm when administered to a pregnant woman. In postmarketing reports, use of trastuzumab during pregnancy resulted in cases of oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death.

Verify the pregnancy status of females of reproductive potential prior to the initiation of ONTRUZANT. Advise pregnant women and females of reproductive potential that exposure to ONTRUZANT during pregnancy or within 7 months prior to conception can result in fetal harm. Advise females of reproductive potential to use effective contraception during treatment and for 7 months following the last dose of ONTRUZANT.

PULMONARY TOXICITY

Trastuzumab product use can result in serious and fatal pulmonary toxicity. Pulmonary toxicity includes dyspnea, interstitial pneumonitis, pulmonary infiltrates, pleural effusions, noncardiogenic pulmonary edema, pulmonary insufficiency and hypoxia, acute respiratory distress syndrome, and pulmonary fibrosis. Such events can occur as sequelae of infusion. Patients with symptomatic intrinsic lung disease or with extensive tumor involvement of the lungs, resulting in dyspnea at rest, appear to have more severe toxicity.

 

EXACERBATION OF CHEMOTHERAPY-INDUCED NEUTROPENIA

In randomized, controlled clinical trials, the per-patient incidences of NCI-CTC Grade 3 to 4 neutropenia and of febrile neutropenia were higher in patients receiving trastuzumab in combination with myelosuppressive chemotherapy as compared to those who received chemotherapy alone. The incidence of septic death was similar among patients who received trastuzumab and those who did not.

DRUG INTERACTIONS

Patients who receive anthracycline after stopping trastuzumab products may be at increased risk of cardiac dysfunction because of trastuzumab’s long washout period based on population PK analysis. If possible, physicians should avoid anthracycline-based therapy for up to 7 months after stopping trastuzumab products. If anthracyclines are used, the patient’s cardiac function should be monitored carefully.

ADVERSE REACTIONS

The most common adverse reactions in patients receiving trastuzumab products in the adjuvant and metastatic breast cancer setting are fever, chills, nausea, vomiting, infusion reactions, diarrhea, infections, increased cough, headache, fatigue, dyspnea, rash, neutropenia, anemia, and myalgia. Adverse reactions requiring interruption or discontinuation of trastuzumab product treatment include CHF, significant decline in left ventricular cardiac function, severe infusion reactions, and pulmonary toxicity.

In the metastatic gastric cancer setting, the most common adverse reactions (≥10%) that were increased (≥5% difference) in the patients receiving trastuzumab as compared to patients receiving chemotherapy alone were neutropenia, diarrhea, fatigue, anemia, stomatitis, weight loss, upper respiratory tract infections, fever, thrombocytopenia, mucosal inflammation, nasopharyngitis, and dysgeusia. The most common adverse reactions which resulted in discontinuation of trastuzumab treatment in the absence of disease progression were infection, diarrhea, and febrile neutropenia.

USE IN SPECIFIC POPULATIONS

LACTATION

There is no information regarding the presence of trastuzumab products in human milk, the effects on the breastfed infant, or the effects on milk production. Published data suggest human IgG is present in human milk but does not enter the neonatal and infant circulation in substantial amounts. Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for ONTRUZANT treatment and any potential adverse effects on the breastfed child from ONTRUZANT or from the underlying maternal condition. This consideration should also take into account the trastuzumab product washout period of 7 months.

PEDIATRIC USE

The safety and effectiveness of trastuzumab products in pediatric patients have not been established.

GERIATRIC USE

Trastuzumab has been studied in patients who were 65 years of age or over in the adjuvant and metastatic breast cancer treatment settings. The risk of cardiac dysfunction was increased in geriatric patients, as compared to younger patients, in both those receiving treatment for metastatic disease or adjuvant therapy.

Before prescribing ONTRUZANT, please read the accompanying Prescribing Information, including the Boxed Warning about cardiomyopathy, infusion reactions (pulmonary toxicity), and embryo-fetal toxicity.

HER2, human epidermal growth factor receptor 2; ER/PR, estrogen receptor/progesterone receptor; FDA, US Food and Drug Administration; MUGA, multigated acquisition; NCI-CTC, National Cancer Institute - Common Terminology Criteria; PK, pharmacokinetics; IgG, Immunoglobulin G.

If you have any questions about ONTRUZANT, please contact your Merck Account Executive.

 

References: 1. Centers for Medicare and Medicaid Services. CMS Manual System; Pub 100-04 Medicare Claims Processing. June 12, 2019. https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2019Downloads/R4320CP.pdf. Accessed March 17, 2020. 2. Centers for Medicare and Medicaid Services. 2020 alpha numeric HCPCS file. https://www.cms.gov/Medicare/Coding/HCPCSReleaseCodeSets/Alpha-Numeric-HCPCS-Items/2020-Alpha-Numeric-HCPCS-File. Accessed March 17, 2020.

Copyright © 2020 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. All rights reserved.

US-SBF-00246 04/20

Corporate Member Aztra Zeneca: New FDA Approval for IMFINZI® (durvalumab)

IMFINZI® (durvalumab)
April, 2020

On Friday, March 27, 2020 the FDA approved IMFINZI® (durvalumab) in combination with standard-of-care (SoC) chemotherapy (etoposide with either carboplatin or cisplatin) in the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).

Approval Based on OS Data from Phase III CASPIAN Trial of IMFINZI

With this approval, IMFINZI becomes the only immunotherapy to demonstrate a significant overall survival benefit in combination with etoposide and either carboplatin or cisplatin in patients with extensive-stage (ES-SCLC). The FDA approval was based on the Phase III CASPIAN results, in which the risk of death was reduced by 27% (equal to a hazard ratio of 0.73), with median overall survival (OS) of 13.0 months (95% CI, 11.5-14.8) for IMFINZI plus chemotherapy vs 10.3 months (95% CI, 9.3-11.2) for SoC chemotherapy alone P=0.00471. Adverse reactions were similar with IMFINZI + EP and EP alone and consistent with the safety profiles for both IMFINZI and EP2.

The CASPIAN trial uses a fixed dose of IMFINZI (1500 mg) administered every three weeks for four cycles while in combination with chemotherapy and then every four weeks as a single agent until disease progression or acceptable toxicity.

Click here for IMFINZI Prescribing Information and read links below for Important Safety Information.

Select Safety Information

Serious, potentially fatal risks were seen with IMFINZI in the CASPIAN trial. The most frequent serious adverse reactions reported in at least 1% of patients were febrile neutropenia (4.5%), pneumonia (2.3%), anemia (1.9%), pancytopenia (1.5%), pneumonitis (1.1%) and COPD (1.1%).

Immune-mediated adverse reactions including immune-mediated pneumonitis, hepatitis, colitis, endocrinopathies (including thyroid disorders, adrenal insufficiency, type 1 diabetes, and hypophysitis), nephritis, dermatologic reactions, other immune-mediated adverse reactions, infection, and infusion-related reactions were reported in patients receiving IMFINZI in the CASPIAN trial. 

The most common adverse reactions (≥20%) were nausea, fatigue/asthenia and alopecia.

Advise women not to become pregnant or breastfeed during treatment with IMFINZI and for at least 3 months after the last dose.

The safety and effectiveness of IMFINZI have not been established in pediatric patients.

Please refer to the Important Safety Information included below and the full Prescribing Information for important dosage modification and management information specific to adverse reactions.

Important Safety Information

Introducing the Updated Copay/Coinsurance Program for Jakafi® (ruxolitinib)

February, 2020

Dear Healthcare Professional,

Eligible Patients Now Pay as Little as $0 Copay Monthly*

As part of our ongoing commitment to provide patients access to the medicines they need, we have updated our Copay/Coinsurance Program.

This program is available to eligible patients who have been prescribed Jakafi for any of its FDA-approved indications.

As of September 30, 2019, eligible patients with commercial or private prescription drug coverage will be able to receive Jakafi for as little as $0 per month. Our previous program allowed eligible patients to pay as little as $25 per month.

Patients who are currently enrolled in the Copay/Coinsurance Program do not need to re-enroll or take any action. They can continue to use their current program card, and their copay/coinsurance amount will automatically be reduced to $0 per month. Eligible new enrollees will receive the new $0 per month program card.

Financial Assistance for Patients Who Do Not Have Insurance

Patients who do not have prescription drug coverage for Jakafi may be eligible to receive Jakafi free of charge through the IncyteCARES Patient Assistance Program.† This program helps people who do not have a prescription drug plan as well as those whose plans will not cover Jakafi. Certain conditions do apply.

You may enroll your eligible patients online through the IncyteCARES digital enrollment form 

  * Update effective as of September 30, 2019. Amount of savings on Jakafi will not exceed $11,977; per month and $25,000 per year, limit one 30-day supply per 30 days. You must have minimum out-of-pocket costs of $.01 to redeem this. Patients will be responsible for any out-of-pocket costs above the maximum annual and monthly program benefit. Card must be activated before use. Card is valid through December 31 of the year of activation. On January 1 of the following year, the card automatically resets and is subject to annual limits if the prescription benefit remains the same. Offer is not valid if you are uninsured or paying cash for your prescription. Offer is not valid if you are enrolled in a federal or state prescription program (including Medicare Part D, Medicare Advantage, Medicaid, TRICARE, or any state medical or pharmaceutical assistance program). If you move or switch from commercial prescription benefit coverage to any government pre scription benefit coverage, you will no longer be eligible. If you have any questions, please call 1-855-4-Jakafi (1-855-452-5234). This card is not insurance. Offer valid only for an FDA-approved use. You are responsible for reporting receipt of program benefits to any commercial or private insurer that pays for or reimburses any part of the prescriptions filled with this program, to the extent required by law or by the insurer. You agree not to seek reimbursement from your insurer or any other third-party for all or any part of the benefit received through this offer. This card may not be sold, purchased, traded, or transferred and is void if reproduced. You agree that you will not in any way report or count the value of the Jakafi provided under this program as true out-of-pocket spending (TrOOP) under a Medicare Part D prescription drug benefit. One card per patient. No substitutions are permitted. Use of this card does not obligate you to use or continue to use Jakafi®. No other purchase and no refills are necessary. This offer is limited to one (1) per person during this offering period and is not transferable. You are responsible for all taxes. Program cards are the property of Incyte Corporation and must be turned in on request. No membership fees. Offer is good only in the United States and Puerto Rico, and void where prohibited or otherwise restricted by law. For Massachusetts residents, this offer expires on January 1, 2020 absent a change in Massachusetts law. Incyte Corporation reserves the right to rescind, revoke, or amend this program without notice.  

Corporate Member Taiho- New Copy Program

Taiho Oncology
January, 2020

Making Access Easier for Patients

Eligible patients may pay $0 per treatment cylce with Taiho Oncology Co-Pay Assistance Program.

To determine patient eligibility, go to TaihoOncologyCopay.com or call 844-824-4648.

If circumstances determine a patient to be significantly underinsured, then Taiho Oncology, Inc. will asssess the patient for support under the Taiho Oncology Patient Assistance Program.

You may be eligible if you:

  • Have commercial prescription insurance coverage
  • Use a specialty pharmacy
  • Use a hospital outpatient pharmacy
  • Receive your medicine from a doctor's office

You may not be eligible if you:

  • Are reimbursed under Medicaid, a Medicare drug benefit program, Tricare, or other state or federal programs
  • Reside outside of the US, Puerto Rico, or US territories

Restrictions and Eligibility:

Offer valid in the US, Puerto Rico, and US territories only. Only valid for patients with private insurance. Offer not valid for prescriptions reimbursed under Medicaid, a Medicare drug benefit plan, Tricare, or other federal or state programs (such as medical assistance programs). If the patient is eligible for drug benefits under any such program, this offer is not valid and the patient cannot use this offer. By presenting or accepting this benefit, patient and pharmacist agree not to submit claim for reimbursement under the above programs. Patient further agrees to comply with any and all terms of his or her health insurance contract requiring notification to his or her payer of the existence and/or value of this offer. It is illegal to or offer to sell, purchase, or trade this benefit. Maximum reimbursement limits apply; patient out-of-pocket expense may vary. Taiho Oncology, Inc., reserves the right to rescind, revoke, or amend this offer at any time without notice.

11/2019

 

Corporate Member Merck - Update

May, 2019

Merck is pleased to announce that KEYTRUDA, as a single agent, has been approved by the FDA for the first-line treatment of patients with stage III non–small cell lung cancer (NSCLC) who are not candidates for surgical resection or definitive chemoradiation, or metastatic NSCLC, and whose tumors express PD-L1 [tumor proportion score (TPS) ≥1%] as determined by an FDA-approved test, with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.

PD-L1 diagnostic testing is required prior to initiating treatment with KEYTRUDA in these patients

KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous NSCLC, with no EGFR or ALK genomic tumor aberrations.

KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.

FDA=Food and Drug Administration; PD-L1=programmed death ligand 1.

Selected Safety Information for KEYTRUDA® (pembrolizumab) injection 100 mg

Immune-mediated adverse reactions, which may be severe or fatal, can occur with KEYTRUDA, including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, severe skin reactions, solid organ transplant rejection, and complications of allogeneic hematopoietic stem cell transplantation (HSCT). Based on the severity of the adverse reaction, KEYTRUDA should be withheld or discontinued and corticosteroids administered if appropriate. For more information regarding immune-mediated adverse reactions, please read the additional Selected Safety Information below.

KEYNOTE-042
First-line Treatment of Metastatic NSCLC as a Single Agent

The efficacy of KEYTRUDA was investigated in KEYNOTE-042 (NCT02220894) a randomized, multicenter, open-label, active-controlled trial conducted in 1274 patients with stage III NSCLC who were not candidates for surgical resection or definitive chemoradiation, or metastatic NSCLC, whose tumors expressed PD-L1 (TPS ≥1%) by an immunohistochemistry assay using the PD-L1 IHC 22C3 pharmDx Kit, and who had not received prior systemic treatment for metastatic NSCLC. Patients with EGFR or ALK genomic tumor aberrations; autoimmune disease that required systemic therapy within 2 years of treatment; a medical condition that required immunosuppression; or who had received more than 30 Gy of radiation in the thoracic region within the prior 26 weeks of initiation of study were ineligible. Randomization was stratified by Eastern Cooperative Oncology Group (ECOG) performance status (0 vs. 1), histology (squamous vs. nonsquamous), geographic region (East Asia vs. non-East Asia), and PD-L1 expression (TPS ≥50% vs. TPS 1 to 49%). Patients were randomized (1:1) to receive KEYTRUDA 200 mg intravenously every 3 weeks or investigator’s choice of either of the following platinum-containing chemotherapy regimens:

Pemetrexed 500 mg/m2 every 3 weeks and carboplatin area under the curve (AUC) 5 to 6 mg/mL/min every 3 weeks on Day 1 for a maximum of 6 cycles followed by optional pemetrexed 500 mg/m2 every 3 weeks for patients with nonsquamous histologies;
Paclitaxel 200 mg/m2 every 3 weeks and carboplatin AUC 5 to 6 mg/mL/min every 3 weeks on Day 1 for a maximum of 6 cycles followed by optional pemetrexed 500 mg/m2 every 3 weeks for patients with nonsquamous histologies.

Treatment with KEYTRUDA continued until Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ)-defined progression of disease, unacceptable toxicity, or a maximum of 24 months. Administration of KEYTRUDA was permitted beyond RECIST-defined disease progression if the patient was clinically stable and deriving clinical benefit as determined by the investigator. Treatment with KEYTRUDA could be reinitiated at the time of subsequent disease progression and administered for up to 12 months. Assessment of tumor status was performed every 9 weeks. The main efficacy outcome measure was overall survival (OS) in the subgroup of patients with TPS ≥50% NSCLC, the subgroup of patients with TPS ≥20% NSCLC, and the overall population with TPS ≥1% NSCLC. Additional efficacy outcome measures were progression-free survival (PFS) and overall response rate (ORR) in the subgroup of patients with TPS ≥50% NSCLC, the subgroup of patients with TPS ≥20% NSCLC, and the overall population with TPS ≥1% NSCLC as assessed by a blinded independent central radiologists’ (BICR) review according to RECIST v1.1, modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ.

The study population characteristics were: median age of 63 years (range: 25 to 90), 45% age 65 or older; 71% male; 64% White, 30% Asian, and 2% Black. Nineteen percent were Hispanic or Latino. Sixty-nine percent had ECOG performance status of 1; 39% with squamous and 61% with nonsquamous histology; 87% with M1 disease and 13% with Stage IIIA (2%) or Stage IIIB (11%) who were not candidates for surgical resection or definitive chemoradiation per investigator assessment; and 5% with treated brain metastases at baseline. Forty-seven percent of patients had TPS ≥50% NSCLC and 53% had TPS 1 to 49% NSCLC.

The trial demonstrated a statistically significant improvement in OS for patients (PD-L1 TPS ≥50%, TPS ≥20%, TPS ≥1%) randomized to KEYTRUDA as compared with chemotherapy. The table below summarizes the efficacy results in the subgroup of patients with TPS ≥50% and in all randomized patients with TPS ≥1%.

Efficacy Results of All Randomized Patients (TPS ≥1% and TPS ≥50%) in KEYNOTE-042

TPS ≥1%
TPS ≥50%

Endpoint

KEYTRUDA
200 mg every 3 weeks n=637

Chemotherapy
n=637

KEYTRUDA
200 mg every 3 weeks n=299

Chemotherapy
n=300

OS

Number of events (%)
371 (58%)
438 (69%)
157 (53%)
199 (66%)

Median in months (95%  CI)
16.7 (13.9, 19.7)
12.1 (11.3, 13.3)
20.0 (15.4, 24.9)
12.2 (10.4, 14.2)

Hazard ratio* (95% CI)
0.81 (0.71, 0.93)
0.69 (0.56, 0.85)

p-Value†
0.0036
0.0006

PFS

Number of events (%)
507 (80%)
506 (79%)
221 (74%)
233 (78%)

Median in months (95%  CI)
5.4 (4.3, 6.2)
6.5 (6.3, 7.0)
7.1 (5.9, 9.0)
6.4 (6.1, 6.9)

Hazard ratio*‡ (95% CI)
1.07 (0.94, 1.21)
0.81 (0.67, 0.99)

p-Value† –‡

NS§

Objective Response Rate
ORR‡ (95% CI)
27% (24, 31)
27% (23, 30)
39% (33.9, 45.3)
32% (26.8, 37.6)

Complete response rate
0.5%
0.5%
0.7%
0.3%

Partial response rate
27%
26%
39%
32%

Duration of Response - % with duration ≥12 months
47%
16%
42%
17%

% with duration ≥18 months
26%
6%
25%
5%

*Based on the stratified Cox proportional hazard model
†Based on a stratified log-rank test; compared to a p-Value boundary of 0.0291
‡Not evaluated for statistical significance as a result of the sequential testing procedure for the secondary endpoints
§Not significant compared to a p-Value boundary of 0.0291
¶Based on observed duration of response
CI=confidence interval.

The results of all efficacy outcome measures in the subgroup of patients with PD-L1 TPS ≥20% NSCLC were intermediate between the results of those with PD-L1 TPS ≥1% and those with PD-L1 TPS ≥50%. In a pre-specified exploratory subgroup analysis for patients with TPS 1-49% NSCLC, the median OS was 13.4 months (95% CI: 10.7, 18.2) for the pembrolizumab group and 12.1 months (95% CI: 11.0, 14.0) in the chemotherapy group, with a hazard ratio of 0.92 (95% CI: 0.77, 1.11).

Recommended Dosage for NSCLC
The recommended dose of KEYTRUDA is 200 mg administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression.

When administering KEYTRUDA in combination with chemotherapy, administer KEYTRUDA prior to chemotherapy when given on the same day. Refer to the Prescribing Information for the chemotherapy agents administered in combination with KEYTRUDA for recommended dosing information, as appropriate.

Selected Safety Information for KEYTRUDA® (pembrolizumab) injection 100 mg

Immune-Mediated Pneumonitis
KEYTRUDA can cause immune-mediated pneumonitis, including fatal cases. Pneumonitis occurred in 8.2% (65/790) of NSCLC patients receiving KEYTRUDA as a single agent, including Grades 3-4 in 3.2% of patients, and occurred more frequently in patients with a history of prior thoracic radiation (17%) compared to those without (7.7%). Monitor patients for signs and symptoms of pneumonitis. Evaluate suspected pneumonitis with radiographic imaging. Administer corticosteroids for Grade 2 or greater pneumonitis. Withhold KEYTRUDA for Grade 2; permanently discontinue KEYTRUDA for Grade 3 or 4 or recurrent Grade 2 pneumonitis.

Immune-Mediated Colitis
KEYTRUDA can cause immune-mediated colitis. Colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 2 (0.4%), 3 (1.1%), and 4 (<0.1%). Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 or greater colitis. Withhold KEYTRUDA for Grade 2 or 3; permanently discontinue KEYTRUDA for Grade 4 colitis.

Immune-Mediated Hepatitis
KEYTRUDA can cause immune-mediated hepatitis. Hepatitis occurred in 0.7% (19/2799) of patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.4%), and 4 (<0.1%). Monitor patients for changes in liver function. Administer corticosteroids for Grade 2 or greater hepatitis and, based on severity of liver enzyme elevations, withhold or discontinue KEYTRUDA.

Immune-Mediated Endocrinopathies
KEYTRUDA can cause hypophysitis, thyroid disorders, and type 1 diabetes mellitus. Hypophysitis occurred in 0.6% (17/2799) of patients, including Grade 2 (0.2%), 3 (0.3%), and 4 (<0.1%). Hypothyroidism occurred in 8.5% (237/2799) of patients, including Grade 2 (6.2%) and 3 (0.1%). Hyperthyroidism occurred in 3.4% (96/2799) of patients, including Grade 2 (0.8%) and 3 (0.1%), and thyroiditis occurred in 0.6% (16/2799) of patients, including Grade 2 (0.3%). Type 1 diabetes mellitus, including diabetic ketoacidosis, occurred in 0.2% (6/2799) of patients.
Monitor patients for signs and symptoms of hypophysitis (including hypopituitarism and adrenal insufficiency), thyroid function (prior to and periodically during treatment), and hyperglycemia. For hypophysitis, administer corticosteroids and hormone replacement as clinically indicated. Withhold KEYTRUDA for Grade 2 and withhold or discontinue for Grade 3 or 4 hypophysitis. Administer hormone replacement for hypothyroidism and manage hyperthyroidism with thionamides and beta-blockers as appropriate. Withhold or discontinue KEYTRUDA for Grade 3 or 4 hyperthyroidism. Administer insulin for type 1 diabetes and withhold KEYTRUDA and administer antihyperglycemics in patients with severe hyperglycemia.

Immune-Mediated Nephritis and Renal Dysfunction
KEYTRUDA can cause immune-mediated nephritis. Nephritis occurred in 0.3% (9/2799) of patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.1%), and 4 (<0.1%) nephritis. Nephritis occurred in 1.7% (7/405) of patients receiving KEYTRUDA in combination with pemetrexed and platinum chemotherapy. Monitor patients for changes in renal function. Administer corticosteroids for Grade 2 or greater nephritis. Withhold KEYTRUDA for Grade 2; permanently discontinue for Grade 3 or 4 nephritis.

Immune-Mediated Skin Reactions
Immune-mediated rashes, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) (some cases with fatal outcome), exfoliative dermatitis, and bullous pemphigoid, can occur. Monitor patients for suspected severe skin reactions and based on the severity of the adverse reaction, withhold or permanently discontinue KEYTRUDA and administer corticosteroids. For signs or symptoms of SJS or TEN, withhold KEYTRUDA and refer the patient for specialized care for assessment and treatment. If SJS or TEN is confirmed, permanently discontinue KEYTRUDA.

Other Immune-Mediated Adverse Reactions
Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue in patients receiving KEYTRUDA and may also occur after discontinuation of treatment. For suspected immune-mediated adverse reactions, ensure adequate evaluation to confirm etiology or exclude other causes. Based on the severity of the adverse reaction, withhold KEYTRUDA and administer corticosteroids. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Based on limited data from clinical studies in patients whose immune-related adverse reactions could not be controlled with corticosteroid use, administration of other systemic immunosuppressants can be considered. Resume KEYTRUDA when the adverse reaction remains at Grade 1 or less following corticosteroid taper. Permanently discontinue KEYTRUDA for any Grade 3 immune-mediated adverse reaction that recurs and for any life-threatening immune-mediated adverse reaction.
The following clinically significant immune-mediated adverse reactions occurred in less than 1% (unless otherwise indicated) of 2799 patients: arthritis (1.5%), uveitis, myositis, Guillain-Barré syndrome, myasthenia gravis, vasculitis, pancreatitis, hemolytic anemia, sarcoidosis, and encephalitis. In addition, myelitis and myocarditis were reported in other clinical trials, including classical Hodgkin lymphoma (cHL), and postmarketing use.
Treatment with KEYTRUDA may increase the risk of rejection in solid organ transplant recipients. Consider the benefit of treatment vs the risk of possible organ rejection in these patients.

Infusion-Related Reactions
KEYTRUDA can cause severe or life-threatening infusion-related reactions, including hypersensitivity and anaphylaxis, which have been reported in 0.2% (6/2799) of patients. Monitor patients for signs and symptoms of infusion-related reactions. For Grade 3 or 4 reactions, stop infusion and permanently discontinue KEYTRUDA.

Complications of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
Immune-mediated complications, including fatal events, occurred in patients who underwent allogeneic HSCT after treatment with KEYTRUDA. Follow patients closely for early evidence of transplant-related complications such as hyperacute graft-versus-host disease (GVHD), Grade 3 to 4 acute GVHD, steroid-requiring febrile syndrome, hepatic veno-occlusive disease (VOD), and other immune-mediated adverse reactions.
In patients with a history of allogeneic HSCT, acute GVHD (including fatal GVHD) has been reported after treatment with KEYTRUDA. Patients who experienced GVHD after their transplant procedure may be at increased risk for GVHD after KEYTRUDA. Consider the benefit of KEYTRUDA vs the risk of GVHD in these patients.

Increased Mortality in Patients With Multiple Myeloma
In trials in patients with multiple myeloma, the addition of KEYTRUDA to a thalidomide analogue plus dexamethasone resulted in increased mortality. Treatment of these patients with a programmed death receptor-1 (PD-1) or PD-L1 blocking antibody in this combination is not recommended outside of controlled trials.

Embryofetal Toxicity
Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. Advise women of this potential risk. In females of reproductive potential, verify pregnancy status prior to initiating KEYTRUDA and advise them to use effective contraception during treatment and for 4 months after the last dose.

Adverse Reactions
In KEYNOTE-189, when KEYTRUDA was administered with pemetrexed and platinum chemotherapy in metastatic nonsquamous NSCLC, KEYTRUDA was discontinued due to adverse reactions in 20% of 405 patients. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA were pneumonitis (3%) and acute kidney injury (2%). The most common adverse reactions (≥20%) with KEYTRUDA were nausea (56%), fatigue (56%), constipation (35%), diarrhea (31%), decreased appetite (28%), rash (25%), vomiting (24%), cough (21%), dyspnea (21%), and pyrexia (20%).
In KEYNOTE-407, when KEYTRUDA was administered with carboplatin and either paclitaxel or paclitaxel protein-bound in metastatic squamous NSCLC, KEYTRUDA was discontinued due to adverse reactions in 15% of 101 patients. The most frequent serious adverse reactions reported in at least 2% of patients were febrile neutropenia, pneumonia, and urinary tract infection. Adverse reactions observed in KEYNOTE-407 were similar to those observed in KEYNOTE-189 with the exception that increased incidences of alopecia (47% vs 36%) and peripheral neuropathy (31% vs 25%) were observed in the KEYTRUDA and chemotherapy arm compared to the placebo and chemotherapy arm in KEYNOTE-407.
In KEYNOTE-042, KEYTRUDA was discontinued due to adverse reactions in 19% of 636 patients; the most common were pneumonitis (3%), death due to unknown cause (1.6%), and pneumonia (1.4%). The most frequent serious adverse reactions reported in at least 2% of patients were pneumonia (7%), pneumonitis (3.9%), pulmonary embolism (2.4%), and pleural effusion (2.2%). The most common adverse reaction (≥20%) was fatigue (25%).
In KEYNOTE-010, KEYTRUDA monotherapy was discontinued due to adverse reactions in 8% of 682 patients with metastatic NSCLC; the most common was pneumonitis (1.8%). The most common adverse reactions (≥20%) were decreased appetite (25%), fatigue (25%), dyspnea (23%), and nausea (20%).

Lactation
Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment and for 4 months after the final dose.

Before prescribing KEYTRUDA® (pembrolizumab), please read the Prescribing Information. The Medication Guide also is available.

 
 
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