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FDA approves Opdivo for treatment of advanced melanoma
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The U.S. Food and Drug Administration has granted accelerated approval to Opdivo as treatment for patients with unresectable and metastatic melanoma who no longer respond to other drugs, according to a press release.
Opdivo (nivolumab, Bristol-Myers Squibb) inhibits the PD-1 protein on cells, which blocks the body’s immune system for attacking melanoma tumors, according to the release. It is indicated for patients with melanoma previously treated with Yervoy (ipilimumab, Bristol-Myers Squib), as well as for those whose tumors express the gene mutation BRAF V600 after treatment with ipilimumab and a BRAF inhibitor.
Richard Pazdur
“Opdivo is the seventh new melanoma drug approved by the FDA since 2011,” Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug and Evaluation and Research, said in the press release. “The continued development and approval of novel therapies based on our increasing understanding of tumor immunology and molecular pathways are changing the treatment paradigm for serious and life-threatening diseases.”
Ipilimumab, Pegasys (peginterferon alfa-2b, Genentech), Zelboraf (vemurafenib, Genentech/Daiichi Sankyo), Tafinlar (dabrafenib, GlaxoSmithKline), Mekinist (trametinib, GlaxoSmithKline) and Keytruda (pembrolizumab, Merck) are the other FDA-approved treatments currently available for the treatment of melanoma.
The FDA approved nivolumab ahead of the prescription drug user fee goal date of March 30, 2015 — the date by which the agency was scheduled to complete the application review, according to the release.
Efficacy of nivolumab was demonstrated in 120 patients with unresectable or metastatic melanoma, with 32% experiencing objective response rate of tumor shrinkage. One-third of the patients who experienced tumor shrinkage had the effect last more than 6 months, according to the release.
Rash, itching, cough, upper respiratory tract infections and edema were common side effects. Serious side effects involved healthy organs, including the lung, colon, liver, kidneys and hormone-producing glands, according to the release.
Reference: www.fda.gov.