Quick FDA approval for Opdivo in NSCLC

Bristol-Myers Squibb Co. (NYSE:BMY) jumped $3.75 to $65.67 on Wednesday after FDA approved an sBLA 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 came more than three months ahead of the drug's June 22 PDUFA date, and just five days after BMS said FDA accepted the sBLA for review.

In January, BMS stopped the Phase III CheckMate-017 trial early after an independent data monitoring committee concluded that Opdivo met the primary endpoint of improving overall survival compared to docetaxel (9.2 months vs. 6 months) (see BioCentury Extra, Jan. 12, 2015). ...