News & Press

FDA Approves Opdivo for Advanced Melanoma

Statement from Tim Turnham, Executive Director

Melanoma Research Foundation

 
Today the FDA approved Opdivo (nivolumab), a new treatment for advanced melanoma, the deadliest form of skin cancer. This approval is a promising development for people with melanoma and opens up an important new avenue to combination therapy, a pivotal approach in treating the disease.
 
Opdivo, developed by Bristol-Myers Squibb (BMS), is one in a class of drugs designed to stimulate the body’s own immune response and targets a protein in the human cell called Programmed Death Receptors (PD-1). Merck’s PD-1 treatment Keytruda (pembrolizumab) was approved in September 2014 and AstraZeneca’s PD-1 drug MEDI4736 is currently in development. 
 
Opdivo has demonstrated encouraging results when used alone and early findings from research suggests it may have the potential to generate exceptionally strong and long-lasting responses when combined with another FDA-approved drug manufactured by BMS, Yervoy (ipilumumab). The research demonstrates increased toxicity when the drugs are combined, making it important for both health care professionals and patients to be educated and vigilant in managing side effects.
 
The melanoma community is encouraged by the strong synergy between nivolumab and ipilumumab. The growing use of combination therapies to treat melanoma signals an important shift in the treatment landscape, and charts important progress in making melanoma a chronic manageable disease. With the approval of more PD-1 drugs and the advancement of combination therapies, we are witnessing much needed progress for the thousands of melanoma patients across the globe. While this approval is a critical step forward, the work does not stop here. Patients need and deserve a treatment that successfully cures this deadly disease. 
 
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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 77,000 Americans are expected to be diagnosed with the disease in 2014, resulting in almost 10,000 deaths. 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 Contacts: 
 
Lauren Smith Dyer
(202) 742-5918
M: (202) 870-8827
 
Jennifer Glicoes
(202) 591-4048 
M: (703) 899-4657