PR Newswire has reported that the FDA has approved the Bristol-Myer’s drug ipilimuab, a treatment for advanced melanoma. Yervoy, the drug’s brand name, will be the only drug on the market designed to treat metastatic melanoma. Yervoy works by immunotherapy, stimulating the immune system and causing it to fight cancer cells. The approval is only for patients who have been unresponsive to other melanoma treatments.
Richard Pazdur, M.D., director of the Office of Oncology Drug Products in the FDA’s centre for Drug Evaluation and Research said, “Late-stage melanoma is devastating, with very few treatment options for patients, none of which previously prolonged a patient’s life. Yervoy is the first therapy approved by the FDA to clearly demonstrate that patients with metastatic melanoma live longer by taking this treatment.”
BMY is seeking to expand approval for first line treatment of melanoma. In an international study measuring survival of melanoma, patients taking Yervoy lived an average of 10 months, but patients receiving an experimental vaccine lived an average of 6.5 months.
Common side effects of Yervoy include fatigue, diarrhoea, skin rash, endocrine deficiencies and colitis. Severe autoimmune reactions were seen in 12.9% of patients. Because of the severe reactions experienced by some patients, the FDA has attached a Risk Evaluation and Mitigation Strategy to Yervoy. This will assure that health care professionals are aware of the possible effects. The FDA will also assure that patients receive a medication guide, warning them of the risks involved.
According to Bristol-Myers’ website, the PDUFA date, the standard time for review by the FDA, for the drug is March 26.
Benzinga has contacted Bristol-Myers but did not receive confirmation or comment regarding the drug or today’s announcement. Benzinga was promised a return call and will provide updates as it receives additional information.
— Gary Cassady
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