Opdivo nivolumab regulatory update

FDA approved an sBLA from Bristol-Myers Squibb for Opdivo nivolumab to treat patients with metastatic squamous non-small cell lung cancer (NSCLC) who have progressed on or after platinum-based chemotherapy. The approval comes more than 3 months ahead of the drug’s June 22 PDUFA date.

The approval was based on data from the open-label, international Phase II CheckMate -063 trial and the open-label, international Phase III CheckMate -017 trial, which was stopped early in January after an IDMC concluded that Opdivo met the primary endpoint of improving overall survival (OS) compared to docetaxel (9.2 months vs. 6 months) (see BioCentury, Jan. 19). ...