10 Apr 2014 6:00 PM • Georgetowne Club - 2440 S. 141st Circle Omaha, NE
Corporate Member Genentech - NEW INDICATION & New Drug(s) :
is a CD20-directed cytolytic antibody and is indicated, in combination with chlorambucil, for the treatment of patients with previously untreated chronic lymphocytic leukemia. (approved 11/1/13)
PERJETA™ (pertuzumab) is a HER2/neu receptor antagonist indicated for treatment of breast cancer. On 09/30/13 the FDA approved its use in combination with trastuzumab and docetaxel as neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer. This indication is based on demonstration of an improvement in pathological complete response rate. No data are available demonstrating improvement in event-free survival or overall survival.
It is also (previously approved) indicated for use in combination with Herceptin® (trastuzumab) and docetaxel for the treatment of patients with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease
(6/2012). ** NCCN Compendia states "“may be considered with trastuzumab with or without cytotoxic therapy (eg, vinorelbine or taxane) for one line of therapy beyond first-line therapy in patients previously treated with chemotherapy and trastuzumab in the absence of pertuzumab” 2/2013.nm
KADCYLA (ADO-TRASTUZUMAB EMTANSINE) is a HER2-targeted antibody and microtubule inhibitor conjugate indicated, as a single agent, for the treatment of patients with HER2-positive, metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. Patients should have either: Received prior therapy for metastatic disease, or Developed disease recurrence during or within six months of completing adjuvant therapy. (Approved 2/22/2013).
TARCEVA (erlotinib) is a kinase inhibitor indicated for: First-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test. Maintenance treatment of patients with locally advanced or metastatic NSCLC whose disease has not progressed after four cycles of platinum- based first-line chemotherapy. Treatment of locally advanced or metastatic NSCLC after failure of at least one prior chemotherapy regimen. First-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer, in combination with gemcitabine. (5/2013)
Corporate Member Seattle Genetics announces an update regarding ADCETRIS (brentuximab vendotin)
A CD30-directed antibody-drug conjugate indicated for: The treatment of patients with Hodgkin lymphoma after failure of autologous stem cell transplant (ASCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not ASCT candidates. The treatment of patients with systemic anaplastic large cell lymphoma after failure of at least one prior multi-agent chemotherapy regimen . The label was updated to state "Continue treatment until disease progression or unacceptable toxicity" (Label change 8/19/13)
Corporate Member Bayer announces new drug Xofigo (radium Ra 223 dichloride) :
XOFIGO (radium Ra 223 dichloride)
Xofigo is an alpha particle-emitting radioactive therapeutic agent indicated for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease. Xofigo was granted FDA approval in May, 2013. (6/2013)
Corporate Member Celgene released New Drug Indication:
ABRAXANE® for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) Initial U.S. Approval: 2005
ABRAXANE is now indicated for the first-line treatment of patients with metastatic adenocarcinoma of the pancreas, in combination with gemcitabine (9/6/13).
ABRAXANE is a microtubule inhibitor previously approved for the treatment of locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC), as first-line treatment in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy and for treatment of Metastatic Breast Cancer, after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated.
REVLIMID (lenalidomide) is a thalidomide analogue indicated for the treatment of patients with: Multiple myeloma (MM), in combination with dexamethasone, in patients who have received at least one prior therapy (1.1). It is also indicated for treatment of transfusion-dependent anemia due to low- or intermediate-1-riskmyelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities (1.2). NEW INDICATION JUNE, 2013: Mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib (1.3).
POMALYST (pomalidomide) is a thalidomide analogue approved in Feb, 2013 for patients with multiple myeloma who have received at least two prior therapies including lenalidomide and bortezomib and have demonstrated disease progression on or within 60 days of completion of the last therapy. Click on the following link to access the REMS online program
REMS CELGENE PRODUCTS
New Corporate Member Medivation has announced new drug:
In August, 2012 the FDA approved XTANDI for use in patients with metastatic prostate cancer. Xtandi is an androgen receptor inhibitor indicated for the treatment of patients with metastatic castration-resistant prostate cancer who have previously received docetaxel.
Corporate Member Pfizer has announced new drug:
On September 4, 2012, The FDA approved bosutinib tablets (Bosulif, Pfizer, Inc) for the treatment of chronic, accelerated, or blast phase Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia (CML) in adult patients with resistance or intolerance to prior therapy.
Corporate Member Eli Lilly new drug indication:
On October 17, 2012, the U. S. Food and Drug Administration expanded labeling to include the results of an additional trial evaluating the safety and efficacy of pemetrexed (ALIMTA, Eli Lilly and Company) for the initial treatment of patients with locally advanced or metastatic, non-squamous, non-small cell lung cancer followed by pemetrexed maintenance in patients whose disease has not progressed after four cycles of platinum and pemetrexed as first-line chemotherapy. Pemetrexed is currently approved, in combination with cisplatin therapy, for the initial treatment of patients with locally advanced or metastatic non-squamous, non-small cell lung cancer and for the maintenance treatment of patients with locally advanced or metastatic nonsquamous non-small cell lung cancer whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. Pemetrexed is not indicated for the treatment of patients with squamous cell lung cancer.
Corporate Member Teva released new drug
On October 26, 2012, the U. S. Food and Drug Administration granted accelerated approval to omacetaxine mepesuccinate, (SYNRIBO for Injection, for subcutaneous use, Teva Pharmaceutical Industries Ltd.), for the treatment of adult patients with chronic or accelerated phase chronic myeloid leukemia (CML) with resistance and/or intolerance to two or more tyrosine kinase inhibitors (TKIs).
Corporate Member Onyx released New Indication:
Stivarga is a kinase inhibitor indicated for the treatment of patients with: Metastatic colorectal cancer (CRC) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti- VEGF therapy, and, if KRAS wild type, an anti-EGFR therapy. Locally advanced, unresectable or metastatic gastrointestinal stromal tumor (GIST) who have been previously treated with imatinib mesylate and sunitinib malate. (4/2013)
KYPROLIS is a proteasome inhibitor indicated for the treatment of patients with multiple myeloma who have received at least two prior therapies including bortezomib and an immunomodulatory agent and have demonstrated disease progression on or within 60 days of completion of the last therapy. Approval is based on response rate. Clinical benefit, such as improvement in survival or symptoms, has not been verified. (7/2012)
Corporate Member Sanofi-Aventis released New Drug:
ZALTRAP (aflibercept) for use in combination with 5-fluorouracil, leucovorin, irinotecan (FOLFIRI) for the treatment of patients with metastatic colorectal cancer (mCRC) that is resistant to or has progressed following an oxaliplatin containing regimen.
Corporate Member Novartis New Drug Indication:
Afinitor (everolimus) indicated for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer (advanced HR+ BC) in combination with exemestane, after failure of treatment with letrozole or anastrozole. (7/2012)
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