publication date: Feb. 2, 2015

FDA Approves Opdivo in Metastatic Melanoma

FDA approved Opdivo (nivolumab) injection for the treatment of patients with unresectable or metastatic melanoma and disease progression following Yervoy (ipilimumab) and, if BRAF V600 mutation positive, a BRAF inhibitor.

This indication was granted under an accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. Opdivo is sponsored by Bristol-Myers Squibb Company.

The efficacy of Opdivo was evaluated based on a single-arm, non-comparative planned interim analysis of the first 120 patients who received Opdivo with a minimum of six months follow-up in the phase III CheckMate-037 trial.

Opdivo achieved a 32 percent response rate (95% CI: 23, 41) with a dosing strength and frequency of 3 mg/kg intravenously over 60 minutes every two weeks. Three percent of patients achieved a complete response, and 28 percent achieved a partial response. Of 38 patients with responses, 33 patients had ongoing responses with durability of response ranging from 2.6+ to 10+ months, which included 13 patients with ongoing responses of six months or longer. Responses to Opdivo were demonstrated in both patients with and without BRAF mutation.


FDA expanded the approved use of Imbruvica (ibrutinib) for previously treated patients with Waldenström’s macroglobulinemia. The drug received a breakthrough therapy designation for this use.

The FDA initially granted Imbruvica accelerated approval in November 2013 for use in patients with mantle cell lymphoma who received one prior therapy. In February 2014, the FDA granted accelerated approval to Imbruvica for use in patients with previously treated chronic lymphocytic leukemia, and then in July 2014, expanded … Continue reading CCL Jan – FDA Approves Opdivo in Metastatic Melanoma

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