Opdivo Granted Accelerated FDA Approval for Melanoma
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.
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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