FDA approves ipilimumab for metastatic melanoma

Issue: April 10, 2011

The monoclonal antibody ipilimumab has received FDA approval for the treatment of metastatic melanoma.

The drug, called Yervoy (Bristol-Myers Squibb), blocks cytotoxic T-lymphocyte antigen or (CTLA-4) and is administered intravenously.

“Late-stage melanoma is devastating, with very few treatment options for patients, none of which previously prolonged a patient’s life,” Richard Pazdur, MD, director of the Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research, said in a press release. “Yervoy is the first therapy approved by the FDA to clearly demonstrate that patients with metastatic melanoma live longer by taking this treatment.”

The drug’s safety and efficacy was demonstrated in a randomized, international study of 676 patients with metastatic melanoma who had stopped responding to other melanoma treatments. The primary endpoint was OS. Patients received ipilimumab plus gp100 or gp100 alone.

Patients assigned to combination therapy lived an average of about 10 months, compared with those assigned to only the vaccine, who lived an average of 6.5 months.

Ipilimumab is being approved with a Risk Evaluation and Mitigation Strategy due to the unusual and severe side effects associated with treatment. Patients will receive a medication guide to inform them of these potential effects.

Common side effects resulting from autoimmune reactions associated with ipilimumab include fatigue, diarrhea, skin rash, endocrine deficiencies (gland or hormone) and colitis. Severe to fatal autoimmune reactions were seen in 12.9% of patients treated with the drug. According to the FDA press release, when severe side effects occurred, the drug was stopped and corticosteroid treatment was started. Not all patients responded to this treatment; those who did respond in some cases did not see any improvement for several weeks.

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