New treatment for advanced melanoma approved by FDA

December 23, 2014

Accelerated approval has been granted by FDA to nivolumab (Opdivo, Bristol-Myers Squibb) for the treatment of patients who have unresectable or metastatic melanoma not responding to treatment with other drugs.

Accelerated approval has been granted by FDA to nivolumab (Opdivo, Bristol-Myers Squibb) for the treatment of patients who have unresectable or metastatic melanoma not responding to treatment with other drugs.

Nivolumab is a drug for use in those patients who were previously treated with ipilimumab and in patients with melanoma who have tumors expressing a gene mutation, BRAF V600, after having been treated with ipilimumab and a BRAF inhibitor. This new agent inhibits PD-1 protein on cells. PD-1 protein blocks the body’s immune system so that it cannot attack melanoma tumors.

FDA granted nivolumab breakthrough therapy designation, as well as priority review and orphan product designation. This occurred because preliminary clinical evidence provided by the sponsor showed that nivolumab may yield a substantial improvement over other currently available therapies; the drug, at the time of application, possessed the potential to be a significant improvement regarding safety and efficacy in the treatment of a serious illness; and nivolumab is a drug intended for the treatment of a rare disease

Read more on breakthrough therapy designation

Nivolumab showed efficacy in 120 clinical trial subjects who had unresectable or metastatic melanoma. In patients administered nivolumab, tumors shrank in 32%. For around one-third of the patients who had tumor shrinkage, the effect from nivolumab lasted for more than 6 months.

In a trial population of 268 study participants who were treated with nivolumab and 102 treated with chemotherapy, the safety of nivolumab was also evaluated. Severe immune-mediated side effects concerned healthy organs such as lungs, colon, liver, kidneys, and hormone-producing glands, whereas common side effects were rash, itching, cough, upper respiratory tract infections, and edema.

Nivolumab is being approved ahead of the prescription drug user fee goal date of March 30, 2015, by more than 3 months. It follows 6 other FDA-approved treatments for melanoma since 2011.

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It has been estimated that more than 76,000 Americans will be diagnosed with melanoma this year, with close to 10,000 dying from this illness.