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FDA Rejects Expanded Indication for Nivolumab (Opdivo)
The FDA has issued a complete response letter (CRL) regarding the supplemental biologics license application (sBLA) for nivolumab (Opdivo, Bristol-Myers Squibb) 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.
The sBLA submitted for nivolumab as a single agent for previously untreated metastatic melanoma was based on clinical data from the phase 3 CheckMate-066 trial, which evaluated nivolumab in treatment-naïve patients with BRAF wild-type advanced melanoma compared with dacarbazine. The FDA approved nivolumab as a single agent for the treatment of patients with BRAF wild-type unresectable or metastatic melanoma, based on results from the CheckMate-066 trial, on November 15. In addition to data from this study, Bristol-Myers Squibb submitted findings for nivolumab in BRAF V600 mutation-positive metastatic melanoma, which was the subject of the FDA’s CRL.
A separate sBLA, which included data from the CheckMate-067 trial evaluating nivolumab as a single agent and in combination with ipilimumab (Yervoy, Bristol-Myers Squibb) in patients with previously untreated advanced melanoma, was accepted by the FDA for review in September and was granted Priority Review with a target action date of January 23, 2016. Data for nivolumab monotherapy in both BRAF wild-type and BRAF V600 mutation-positive advanced melanoma was included as part of this application.
Source: Bristol-Myers Squibb, November 27, 2015