FDA pushes back action date on expanded approval of Bristol-Myers' Opdivo

US pharma major Bristol-Myers Squibb (NYSE: BMY) said that the Food and Drug Administration has extended the action date for its application for expanded approval of Opdivo (nivolumab) to include patients with previously-untreated advanced melanoma.

It has submitted additional data from the clinical trial program to the FDA, and the additional time needed to review this “major amendment” has meant the action date has been pushed back by three months to November 27.

The supplemental application was accepted and awarded priority review by the FDA in April, supported by data from the Phase III CheckMate-066 trial evaluating Opdivo against dacarbazine in treatment-naive patients with BRAF wild-type advanced melanoma.