FDA Approves Cotellic for Advanced Melanoma

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FDA Approves Cotellic for Advanced Melanoma
FDA Approves Cotellic for Advanced Melanoma

TUESDAY, Nov. 10, 2015 (HealthDay News) -- Cotellic (cobimetinib) in combination with another chemotherapy, vemurafenib (Zelboraf), has been approved by the U.S. Food and Drug Administration to treat melanoma skin cancer that has spread or cannot be surgically removed, and that has a BRAF V600E or V600K mutation, the agency said Tuesday in a news release.

The FDA said it has approved various tests to confirm the presence of either gene abnormality. Health care providers should utilize one of these tests to confirm the presence of BRAF V600 E or V600K mutation in their patients' tumor specimens prior to starting treatment with Cotellic in combination with Zelboraf, according to the agency.

In clinical testing involving 495 people, the Cotellic/Zelboraf combination delayed cancer progression an average of 12.3 months, compared to 7.2 months among those who took Zelboraf alone. And about 65 percent of people who took the drug combination were still alive after 17 months, compared to 50 percent of people who took the single drug and a placebo, the FDA said.

The most common side effects of the Cotellic/Zelboraf combination included diarrhea, sensitivity to ultraviolet light, nausea and vomiting, and fever. Cotellic may cause more serious adverse reactions, including cardiomyopathy, rhabdomyolysis, primary cutaneous malignancies, retinal detachment, and skin rash. Users should avoid sun exposure, and female users of child-bearing age should use contraception since the drug can harm a fetus, the agency warned.

Both Cotellic and Zelboraf are marketed by Genentech, based in San Francisco.

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