FDA Approves Bristol Myers' Opdivo Plus Chemo In Neoadjuvant Lung Cancer Setting

The FDA has approved Bristol Myers Squibb Co's BMY Opdivo (nivolumab) in combination with platinum-doublet chemotherapy for resectable non-small cell lung cancer (NSCLC) in the neoadjuvant setting.

• The agency approved the Opdivo combo just five days after accepting the application.
• The approval marks the first-and-only immunotherapy-based treatment for use before surgery for non-small cell lung cancer.
• Opdivo-based combinations are now approved in metastatic and earlier non-small cell lung cancer stages.
• Opdivo plus chemotherapy is approved regardless of PD-L1 status.
• The approval is based on the CheckMate -816 trial. Opdivo plus chemo showed a statistically significant improvement in event-free survival with a 37% reduction in the risk of progression, recurrence, or death compared to chemotherapy alone.
• Opdivo plus chemotherapy showed a median EFS of 31.6 months compared to 20.8 months for patients treated with chemotherapy alone.
• Additionally, 24% of patients treated with Opdivo plus chemotherapy achieved pCR, compared to 2.2% of patients treated with chemotherapy alone.
• Price Action: BMY shares closed 0.14% lower at $69.25 during after-hours trading on Friday.