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

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

 
 
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