FDA approves extension of Opdivo (nivolumab) to include metastatic NSCLC where disease has progressed after platinum chemotherapy- BMS

The FDA has approved Opdivo (nivolumab), from BMS, to treat patients with advanced (metastatic) non-small cell lung cancer whose disease progressed during or after platinum-based chemotherapy.

The safety and effectiveness of nivolumab for this use was demonstrated in an international, open-label, randomised study of 582 participants with advanced NSCLC whose disease progressed during or after treatment with platinum-based chemotherapy and appropriate biologic therapy. Participants were treated with nivolumab or docetaxel. The primary endpoint was overall survival, and the secondary endpoint was objective response rate (the percentage of patients who experienced complete or partial shrinkage of their tumours). Those treated with Opdivo lived an average of 12.2 months compared to 9.4 months in those treated with docetaxel. Additionally, 19% of those treated with nivolumab experienced a complete or partial shrinkage of their tumours, an effect that lasted an average of 17 months, compared to 12% among those taking docetaxel, which lasted an average of 6 months.The level of PD-L1 expression in NSCLC tumours may help identify patients who are more likely to live longer due to treatment with nivolumab. Therefore, the FDA also approved the PD-L1 IHC 28-8 pharmDx test to detect PD-L1 protein expression levels and help physicians determine which patients may benefit most from treatment with nivolumab.