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