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Return to: PBR Home | Regulatory Affairs Regulatory Affairs News FDA declines to approve expanded use of Bristol-Myers Squibb’s Opdivo drug
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FDA declines to approve expanded use of Bristol-Myers Squibb’s Opdivo drug

PBR Staff WriterPublished 30 November 2015

The US Food and Drug Administration (FDA) has declined to approve Bristol-Myers Squibb’s Opdivo (nivolumab) drug for its expanded use to treat an additional type of advanced skin cancer.

Bristol-Myers Squibb planned to use the drug a single agent to treat previously untreated patients, specifically those with BRAF V600 mutation positive unresectable or metastatic melanoma.

The company received a complete response letter from the FDA, which indicated the need for additional data in the BRAF mutated patient population.

Bristol-Myers Squibb is working to address the FDA’s requirements. The company said it will continue to work with the agency to identify whether additional information, currently under review, adequately addresses the comments.

The supplemental biologics license application (sBLA) submitted to the agency was based on clinical data from the Phase 3 CheckMate -066 trial which evaluated Opdivo in treatment-naïve patients with BRAF wild-type advanced melanoma compared to dacarbazine.

Earlier this month, the FDA approved Opdivo as a single agent to treat patients with BRAF wild-type unresectable or metastatic melanoma.

The company submitted data for Opdivo in BRAF V600 mutation positive metastatic melanoma, which was the subject of the FDA’s complete response letter.

In September, the FDA accepted for review a separate sBLA, which included data from CheckMate -067 evaluating Opdivo as a single agent and in combination with Yervoy (ipilimumab) in patients with previously untreated advanced melanoma.

It was granted priority review with a target action date of 23 January 2016.

Courtesy – PBR



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