BRIEF—Latest Opdivo sBLA accepted by FDA

The US Food and Drug Administration (FDA) has accepted for priority review Bristol-Myers Squibb’s supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) to treat patients with melanoma who are at high risk of disease recurrence following complete surgical resection.

The FDA also previously granted Breakthrough Therapy Designation for this application, which is the seventh indication for which Opdivo, a PD-1 checkpoint inhibitor that has become one of the leading drugs in the first wave of immune-oncology agents, has received this designation.

This application is based on data from the ongoing Phase III CheckMate -238 study.