Beefed-Up Submission Delays Opdivo's 1st-Line Melanoma Timeline
This article was originally published in Scrip
Executive Summary
The FDA said it needed more time to review Bristol-Myers Squibb's supplemental biologics license application (sBLA) for its programmed death-1 immune checkpoint inhibitor Opdivo (nivolumab) as a first-line monotherapy for advanced melanoma after the company decided to beef up its submission with additional data.