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FDA Approves Opdivo and Yervoy Combination for Advanced Melanoma


Statement from Tim Turnham, Executive Director, Melanoma Research Foundation

The Melanoma Research Foundation (MRF) applauds the FDA’s approval of the combination of Opdivo (nivolumab) and Yervoy (ipilimumab) for patients with previously untreated BRAF wild-type advanced melanoma. Today’s approval marks a turning point in melanoma treatment. For the first time patients will have access to a regimen that utilizes two critical findings—that the patient’s own immune system can be engaged in the fight against cancer, and that the right combination of two or more drugs can have a synergistic effect.
Studies combining Opdivo and Yervoy, both developed by Bristol-Myers Squibb, show a much stronger response rate from people with previously untreated late-stage melanoma compared to Yervoy alone. Data from one study of the combination reported an objective response rate of 61% in previously untreated advanced melanoma patients, a number that would have been inconceivable just five years ago. 
Both Opdivo and Yervoy are FDA-approved to treat advanced melanoma as monotherapies, or as independent treatments. Yervoy, an immunotherapy, was approved in 2011 after almost 13 years without a new treatment for advanced melanoma. Opdivo was approved by the FDA in late 2014. Both drugs are part of a class of drugs called “checkpoint inhibitors” which disable the body’s natural mechanisms for limiting the immune system. Immunotherapies have been shown to be effective in treating people with advanced melanoma. The combination of these two treatments result in an aggressive and innovative approach to fighting growing melanoma cells. 
Melanoma researchers and scientists across the world agree the cure for melanoma is hiding in combination therapies. Key to this, however, is identifying the specific treatment for each individual patient that will result in a positive response. The combination of Yervoy and Opdivo brings the melanoma community one important step closer to finding the solution to this cancer.
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About Melanoma
Melanoma is one of the fastest growing cancers in the United States and can strike men and women of all ages, all races and skin types. With a one in 50 lifetime risk of developing melanoma, nearly 74,000 Americans are expected to be diagnosed with Stage I-IV melanoma and another 63,000 will be diagnosed with melanoma in situ – totaling nearly 137,000 total diagnoses. Melanoma is the most common form of cancer for young adults 25- to 29-years-old and the second most common cancer in adolescents and young adults 15- to 29-years-old. 
The majority of melanomas occur on the skin; in fact, melanoma is the most serious type of skin cancer. Melanoma can also occur in the eye (ocular, or uveal melanoma), in mucous membranes (mucosal melanoma), or even beneath fingernails or toenails. 
About the Melanoma Research Foundation
The Melanoma Research Foundation (MRF) is the largest independent organization devoted to melanoma. Committed to the support of medical research in finding effective treatments and eventually a cure for melanoma, the MRF also educates patients and physicians about prevention, diagnosis and the treatment of melanoma. The MRF is an active advocate for the melanoma community, helping to raise awareness of this disease and the need for a cure. The MRF’s website is the premier source for melanoma information seekers. More information is available at www.melanoma.org. Find the MRF on Facebook and Twitter.
Media Contact:
Lauren Smith Dyer
(202) 742-5918
M: (202) 870-8827