Bristol-Myers Squibb has announced in a press release that the U.S. Food and Drug Administration (FDA) published a Complete Response Letter for its supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) as a single agent for the first treatment of patients with BRAF V600 mutation positive unresectable or metastatic melanoma.
In its letter, the FDA requested more data in the BRAF mutated patient population, which Bristol-Myers is currently gathering.
The FDA approved Opdivo, based on Bristol-Myers’ sBLA submission, as a single agent for formerly untreated metastatic melanoma. The submission drew on clinical data from its Phase 3 clinical trial, CheckMate-066, evaluating Opdivo compared to dacarbazine in treatment-naïve patients with BRAF wild-type advanced melanoma.
In addition, a second sBLA including data from CheckMate-067 — which evaluated Opdivo as a single agent and in combination with Yervoy (ipilimumab) in patients with untreated advanced melanoma — was accepted by the FDA and granted Priority Review status, with the target action date of Jan. 23, 2016. All data for Opdivo monotherapy in both BRAF wild-type and BRAF V600 mutation positive advanced melanoma was included in this application.
Bristol-Myers Squibb, a biopharmaceutical company working to develop and deliver novel medicines to patients with serious diseases, focuses on long-term survival and quality of life for advanced cancer patients. The company believes immunotherapy research can present alternatives to surgery, radiation, or cytotoxic therapies. As a result of a collaboration with Ono Pharmaceutical Co., Bristol-Myers expanded its rights to commercialize Opdivo worldwide.
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