FDA Approves Pembrolizumab for Advanced Melanoma - Applied Clinical Trials

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FDA Approves Pembrolizumab for Advanced Melanoma Statement from Tim Turnham, Executive Director, Melanoma Research Foundation


FDA Approves Pembrolizumab for Advanced Melanoma

Statement from Tim Turnham, Executive Director, Melanoma Research Foundation

PR Newswire

WASHINGTON, Sept. 4, 2014 /PRNewswire-USNewswire/ -- Today the FDA approved Keytruda (pembrolizumab), a new treatment for advanced melanoma, the deadliest form of skin cancer. Melanoma patients have been waiting anxiously for this day, given the promising data that early studies have shown. In clinical trials, 24 percent of patients taking pembrolizumab had their tumors shrink. Most of these patients continued to respond past the 8.5 month study cut off. This is particularly significant because these studies were conducted in patients who had already failed to respond to other approved therapies. The approval of pembrolizumab is a tremendous step forward for the melanoma patient community, as this is the most promising and positive patient response to a melanoma treatment to date. 

Pembrolizumab, developed by Merck, is the first melanoma drug approved by the FDA that targets a protein in the human cell called Programmed Death Receptors (PD-1). This innovative approach to combatting melanoma is highly regarded by researchers, many of whom feel PD-1 therapies will be the key to treating advanced melanoma and possibly several other cancers successfully. Other companies in the process of creating their own PD-1 treatments include Bristol-Myers Squibb (BMS) and AstraZeneca. Approval of the BMS PD-1 is expected in the next few months.

With the approval of Merck's PD-1, we are witnessing a giant leap toward a long-term and durable solution to helping people put their melanoma behind them for good. After many years without new treatments, five melanoma treatments have now been approved by the FDA since 2011, indicating major progress in treatments for people diagnosed with this deadly disease. Prior to today's approval, the median survival of a person diagnosed with advanced melanoma was less than a year. 

While today's approval is a critically important milestone, much work remains to be done. Pembrolizumab will not be a treatment option for every person with late stage melanoma and not everyone who takes it will have positive results. While many people who were administered pembrolizumab in clinical trials saw tremendous benefit, a treatment that successfully kills melanoma cells and prevents recurrence in every patient has not yet been developed. That is the ultimate goal. 

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.

SOURCE Melanoma Research Foundation

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