FDA letter calls for more data on Opdivo sBLA

The US Food and Drug Administration on Friday declined to approve expanded use of Pharma major Bristol-Myers Squibb’s (NYSE: BMY) Opdivo (nivolumab) based on current data.

The agency has issued a Complete Response Letter for the company’s supplemental Biologics License Application (sBLA) for Opdivo as a single agent for the treatment of previously untreated patients, specifically those with BRAF V600 mutation positive unresectable or metastatic melanoma.

As part of the CRL, the FDA indicated the need for additional data in the BRAF mutated patient population. Bristol-Myers Squibb says is working to evaluate the request outlined by the FDA and will continue to work closely with the agency to determine whether additional data, currently under review, adequately addresses these comments.