The U.S. Food and Drug Administration (FDA) has granted approval for Bristol Myers Squibb’s (BMS, NYSE: BMY) Opdivo (nivolumab) for use in combination with platinum-based chemotherapy as a neoadjuvant treatment for adult patients with resectable non-small cell lung cancer (NSCLC), followed by Opdivo as an adjuvant treatment post-surgery. This decision comes as a significant expansion for the application of Opdivo in the fight against lung cancer, a disease that affects millions of patients worldwide.
The approval was based on the positive outcomes from the Phase 3 CHECKMATE-77T trial, a double-blind, placebo-controlled study that evaluated the efficacy and safety of Opdivo in 461 patients with untreated, resectable NSCLC. The trial’s primary endpoint, event-free survival (EFS), showed a median EFS that was not reached in the Opdivo group, compared to 18.4 months in the chemotherapy group, with a 42% reduction in the risk of disease progression.
Adverse events were in line with previous experiences with Opdivo combined with chemotherapy. Notably, 5.3% of patients in the Opdivo neoadjuvant group could not undergo surgery due to adverse events, versus 3.5% in the placebo group. Additionally, 4.5% of patients in the Opdivo group had their surgery delayed due to adverse events, compared to 3.9% in the placebo group.
Opdivo, a PD-1 immune checkpoint inhibitor, is designed to enhance the body’s immune response against cancer cells. This FDA approval adds to the growing list of indications for Opdivo, which has already provided treatment to over 35,000 patients in its clinical development program.- Flcube.com
