Bristol Myers' Opdivo Under Priority FDA Review In Neoadjuvant Lung Cancer Setting

The FDA has accepted for review Bristol-Myers Squibb Co's BMY supplemental application for Opdivo (nivolumab) plus chemotherapy for resectable non-small cell lung cancer (NSCLC) in a neoadjuvant setting.

• Under the Priority Review status, the agency has assigned a Prescription Drug User Fee Act (PDUFA) goal date of July 13, 2022.
• The filing was based on the pivotal CheckMate -816 study results, the first positive Phase 3 trial with an immunotherapy-based combination in the neoadjuvant setting of NSCLC.
• Also See: Bristol Myers, Exelixis Tout Additional Opdivo/Cabometyx Combo Data From Kidney Cancer Trial.
• In the trial, Opdivo plus chemotherapy demonstrated a statistically significant and clinically meaningful improvement in pathologic complete response (pCR) and event-free survival (EFS) versus chemotherapy alone when given before surgery. 
• Price Action: BMY shares are down 1.07% at $68.07 during the market session on the last check Monday.