FDA approves Opdivo (nivolumab) for treatment of NSCLC- BMS

BMS has announced that the FDA has approved Opdivo (nivolumab) injection, for intravenous use, for the treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Opdivo is the first and only PD-1 (programmed death receptor-1) therapy to demonstrate overall survival in previously treated metastatic squamous NSCLC.

Opdivo demonstrated significantly superior overall survival (OS) vs. docetaxel, with a 41% reduction in the risk of death (hazard ratio: 0.59 [95% CI: 0.44, 0.79; p=0.00025]), in a prespecified interim analysis of a Phase III clinical trial. The median OS was 9.2 months in the Opdivo arm (95% CI: 7.3, 13.3) and 6 months in the docetaxel arm (95% CI: 5.1, 7.3).

Comment: There are several companies developing programmed cell death drugs (PD-1 inhibitors). Merck Inc. has Keytruda (pembrolizumab) and Genentech/ Roche has RG 7446 , both in Phase III trials and a little behind is MEDI 4736 from AstraZeneca/Medimmune. Opdivo already has accelerated approval for unresectable metastatic melanoma and as the first drug of the class to have NSCLC approval is likely to lead the market.