The combination packs a potent one-two punch against the most aggressive types of melanoma.
In May 2013, the FDA approved both drugs as single agents to treat advanced melanoma. Tafinlar is a BRAF inhibitor that targets tumors that express the BRAF V600E gene mutation. Mekinist, a MEK inhibitor, is approved to treat tumors that express the BRAF V600E or V600K gene mutations. About 50 percent of melanomas have BRAF gene mutations. The FDA has also approved a companion genetic test to determine if a melanoma expresses either of these BRAF mutations.
The approval of the combination is based on a study of 162 people with advanced melanoma with the BRAF V600E or V600K mutation. Participants received either Mekinist in combination with Tafinlar or Tafinlar alone until their melanoma progressed or side effects became intolerable.
Fully 76 percent of participants treated with the combination had their cancer shrink or disappear for about 10.5 months. By contrast, 54 percent of participants treated with Tafinlar alone showed improvements in their cancer that lasted an average of 5.6 months. Whether or not the combination will improve survival for these individuals remains to be seen.
Side effects of the drug combo include fever, chills, tiredness, rash, nausea, vomiting, diarrhea, abdominal pain, swelling in the hands and feet, cough, headache, joint pain, night sweats, decreased appetite, constipation and muscle pain. One potentially serious side effect of Tafinlar is the development of squamous cell skin cancer, but the risk was lessened when the drug was used in combination with Mekinist.
No Reason to Die from Melanoma
Calling the new approval a "game changer," San Diego-based dermatologist Mona Z. Mofid, M.D, the Medical Director of the American Melanoma Foundation, explains that for years there was nothing available to treat advanced melanoma. "Now we have all of these great new medications that can be used alone or in combination."
Despite new drugs, sun protection and early detection remain the best path to take. "One person dies every hour from melanoma across all age groups and geographic and ethnic lines," she says. "There should be no reason to die from melanoma. With early detection, it is generally completely curative," she says.
Gary Goldenberg, MD, an assistant professor of dermatology and pathology at Mount Sinai Medical Center in New York City, agrees. "[The new FDA approval] is an important step in treatment of patients with advanced melanoma, but prevention and early detection, however, are still the best option for patients."
Mekinist and Tafinlar are marketed by GlaxoSmithKline, based in Research Triangle Park, N.C.
Additional reporting by Denise Mann
Wendy Lewis is President of Wendy Lewis & Co Ltd Global Aesthetics Consultancy, author of 11 books and Founder/Editor in Chief of http://www.beautyinthebag.com.
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