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FDA Approves Nivolumab for Advanced Melanoma

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The U.S. Food and Drug Administration (FDA) today granted accelerated approval to nivolumab (Opdivo) for patients with unresectable or metastatic melanoma who no longer respond to other drugs. Nivolumab, a PD-1 inhibitor, is intended for patients who have been previously treated with ipilimumab (Yervoy) and, for melanoma patients whose tumors express the BRAF V600 mutation, for use after treatment with ipilimumab and a BRAF inhibitor.

“[Nivolumab] is the seventh new melanoma drug approved by the FDA since 2011,” said Richard Pazdur, MD, Director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “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.”

Clinical Trial

Nivolumab’s efficacy was demonstrated in 120 clinical trial participants with unresectable or metastatic melanoma. The drug demonstrated an objective response rate of 32%, and this effect lasted for more than 6 months in approximately one-third of the participants who experienced tumor shrinkage.

Nivolumab’s safety was evaluated in the overall trial population of 268 participants treated with nivolumab and 102 participants treated with chemotherapy. The most common side effects of the drug were rash, itching, cough, upper respiratory tract infections, and edema. The most serious side effects are severe immune-mediated side effects involving healthy organs, including the lung, colon, liver, kidneys, and hormone-producing glands.

Approval Process

Nivolumab is being approved more than 3 months ahead of the prescription drug user fee goal date of March 30, 2015.

The FDA granted nivolumab Breakthrough Therapy designation, priority review, and Orphan Product designation because the sponsor demonstrated through preliminary clinical evidence that the drug may offer a substantial improvement over available therapies; the drug had the potential, at the time of the application was submitted, to be a significant improvement in safety or effectiveness in the treatment of a serious condition; and the drug is intended to treat a rare disease, respectively.

Nivolumab is being approved under the FDA’s accelerated approval program, which allows approval of a drug to treat a serious or life-threatening disease based on clinical data showing the drug has an effect on a surrogate endpoint reasonably likely to predict clinical benefit to patients. This program provides earlier patient access to promising new drugs while the company conducts additional clinical trials to confirm the drug’s benefit.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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