FDA grants accelerated approval to Bristol-Myers Squibb's Opdivo for melanoma

Bristol-Myers Squibb said Monday that the FDA awarded accelerated approval to the PD-1 inhibitor Opdivo (nivolumab) for the treatment of patients with unresectable or metastatic melanoma who no longer respond to other drugs. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, remarked "Opdivo is the seventh new melanoma drug approved by the FDA since 2011."

The efficacy of the therapy was supported by data from a clinical trial of 120 patients with unresectable or metastatic melanoma. In the study, 32 percent of treated patients experienced tumour shrinkage, with the effect lasting for more than six months in about one-third of the patients. Meanwhile, Bristol-Myers Squibb announced last month that Opdivo was linked to increased overall survival versus dacarbazine in a late-stage study of patients with advanced melanoma.

Opdivo was launched earlier this year in Japan at an average annual cost of $143 000, marking the first PD-1 inhibitor to be marketed anywhere in the world. The therapy is the second drug in the class cleared by the FDA for the treatment of unresectable or metastatic melanoma following the approval of Merck & Co.'s Keytruda (pembrolizumab) in September.

For related analysis, see ViewPoints: New cancer filings and approvals already overshadowed by PD-1 competitors?

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