Bristol Myers' $10B Cancer Drug Opdivo Scores Expanded Use FDA Approval For Lung Cancer In Pre And Post-Surgery Setting

On Thursday, the FDA approved Bristol Myers Squibb & Co’s (NYSE:BMY) Opdivo (nivolumab) for resectable non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements, for neoadjuvant treatment, in combination with platinum-doublet chemotherapy, followed by single-agent Opdivo as adjuvant treatment after surgery. The approval is based on results from the CheckMate-77T trial, the company’s second Phase 3 trial with an immunotherapy-based combination for resectable NSCLC. Opdivo is now the only PD-1 inhibitor to demonstrate statistically significant and clinically meaningful benefits in this disease versus chemotherapy in both a neoadjuvant-only regimen and as part of a ...