The Food and Drug Administration has granted accelerated approval for Opdivo (nivolumab; Bristol-Myers Squibb) injection for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab (Yervoy) and, if BRAF V600 mutation positive, a BRAF inhibitor.

Opdivo is a human programmed death receptor-1 (PD-1) blocking antibody that works to prevent the inhibition of the immune system in attacking the melanoma tumors. Its efficacy was established in patients with unresectable or metastatic melanoma (n=120). Results showed that 32% of patients treated with Opdivo had shrinkage in their tumors. About one-third of the patients with tumor shrinkage achieved the objective response rate of six months.

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Opdivo was granted breakthrough therapy designation, priority review, and orphan drug designation. Opdivo will be available as 40mg/4mL or 100mg/10mL strengths in single-use vials.

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