Bristol-Myers Squibb announced that the Food and Drug Administration (FDA) has issued a Complete Response Letter to the supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) 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 Complete Response Letter, the FDA is requesting additional data in the BRAF mutated patient population. Bristol-Myers Squibb is working closely with the FDA to evaluate and address the agency’s request.
Opdivo was approved by the FDA as a single agent for the treatment of patients with BRAF wild-type unresectable or metastatic melanoma on November 23, 2015. The approval was based on results from the Phase 3 clinical trial CheckMate -06. In addition to data from the trial, the company submitted data for Opdivo in BRAFV600 mutation positive metastatic melanoma, which was the subject of the FDA’s Complete Response Letter.
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