FDA Approves Opdivo for the Treatment of Melanoma

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Approval of anti-PD-1 antibody Opdivo represents a major milestone for patients who no longer respond to existing treatments for melanoma.

FDA announced on Dec. 22, 2014 that it granted accelerated approval to the PD-1 inhibitor Opdivo (Nivolumab) for the treatment of unresectable or metastatic melanoma for patients who no longer respond to other medications. Opdivo is the seventh new melanoma drug approved by FDA since 2011, according to a comment by Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation, in a press release.

FDA granted Opdivo Breakthrough Therapy, Priority Review, and Orphan Product designations, as Bristol-Myers Squibb (BMS) showed that the drug offered substantial improvement over available therapies. These therapies include ipilimumab, peginterferon alfa-2b, vemurafenib, dabrafenib, trametinib, and pembrolizumab.

Opdivo shrank the tumors of 32% of participants receiving the drug in clinical trials, and is the only PD-1 that has demonstrated efficacy in a Phase III, pivotal clinical trial of patients with advanced melanoma who have progressed following first line therapy, according to a BMS press release. It was approved three months ahead of the anticipated prescription drug user fee date of March 30, 2015.


An analysis by market intelligence firm EvaluatePharma identified Opdivo as the biggest US launch of 2015, with estimated annual sales of $658 million in 2015 and $7.1 billion by 2020. The group predicts Opdivo will be among the top 10 worldwide sellers by 2020, along with blockbusters such as Harvoni (ledipasvir and sofosbuvir), Solvaldi (sofosbuvir), Remicade (infliximab), Humira (adalimumab), Avastin (bevacizumab), and others.

Bristol-Myers Squibb