Bristol-Myers to Update FDA on Potential Metastatic Melanoma Treatment

Bristol-Myers to Update FDA on Potential Metastatic Melanoma Treatment

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.

Other Recent News

Researchers at the Tisch Cancer Institute at the Icahn School of Medicine at Mount Sinai revealed a new mechanism by which radiotherapy can successfully eradicate melanoma. These findings were published in Nature Immunology in a study entitled “CDKN1A regulates Langerhans cell survival and promotes Treg cell generation upon exposure to ionizing irradiation.”

Inês holds a PhD in Biomedical Sciences from the University of Lisbon, Portugal, where she specialized in blood vessel biology, blood stem cells, and cancer. Before that, she studied Cell and Molecular Biology at Universidade Nova de Lisboa and worked as a research fellow at Faculdade de Ciências e Tecnologias and Instituto Gulbenkian de Ciência. Inês currently works as a Managing Science Editor, striving to deliver the latest scientific advances to patient communities in a clear and accurate manner.
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Inês holds a PhD in Biomedical Sciences from the University of Lisbon, Portugal, where she specialized in blood vessel biology, blood stem cells, and cancer. Before that, she studied Cell and Molecular Biology at Universidade Nova de Lisboa and worked as a research fellow at Faculdade de Ciências e Tecnologias and Instituto Gulbenkian de Ciência. Inês currently works as a Managing Science Editor, striving to deliver the latest scientific advances to patient communities in a clear and accurate manner.
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