FDA Approves First New Adjuvant Treatment for Stage III Melanoma Patients in 20 Years

 

Washington, D.C.—Today the Food and Drug Administration (FDA) approved ipilimumab (Yervoy) for use as a way to lower the risk of recurrence for melanoma patients who have had their tumors removed through surgery. This approval means Stage III melanoma patients have a powerful new tool to help prevent their disease from progressing.

 

Treatment for Stage III patients has historically been challenging, with fewer options available. A Stage III diagnosis means that melanoma cells have been found in lymph nodes. It is difficult to predict whether these cells will remain dormant indefinitely or if they will spread and form new tumors. Following the initial surgical treatment, some Stage III patients chose to undergo Interferon as an adjuvant treatment. For many, however, the standard of care following the initial surgery treatment has been to remain under close observation by their physicians, rather than seek active treatment. Today’s approval marks the first new FDA approved adjuvant option in 20 years.

 

According to clinical trial results reported in the journal, The Lancet Oncology, in May 2015, the median recurrence-free survival of patients taking ipilimumab as an adjuvant therapy was approximately 26 months versus 17 months in the placebo group. Many patients taking ipilimumab experienced relatively severe side-effects, with the most common being gastrointestinal. In fact, 52% of patients taking ipilimumab in the trial experienced adverse side effects severe enough to discontinue treatment. 

 

Although some patients might encounter adverse reactions to the treatment, it is important to note that today’s approval represents another option for people fighting this deadly cancer. 

 

Ipilimumab was approved as a treatment for patients with unresectable or metastatic melanoma in 2011. Click here to learn more about ipilimumab or visit Bristol-Myer Squibb’s official announcement here.

 

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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. 

 

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.melaresearcstg.wpengine.com. Find the MRF on Facebook and Twitter.

 

Media Contact:
Lauren Smith Dyer

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Jennifer Glicoes

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