In announcing the regulatory delay for Bristol-Myers Squibb Co.’s first-line melanoma filing for Opdivo (nivolumab), the company appears to be signaling that it expects approval in both BRAF wild-type and mutant patients – which would be bad news for BRAF inhibitors.
The supplemental Biologics License Application (sBLA) for previously untreated advanced melanoma was accepted for review in April and has been under priority review at the FDA with an Aug. 27...