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For Immediate Release: May 29, 2013
Media Inquiries: Stephanie Yao, 301-796-0394,
Consumer Inquiries: 888-INFO-FDA

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FDA approves two drugs, companion diagnostic test for advanced skin cancer

The U.S. Food and Drug Administration today approved two new drugs, Tafinlar (dabrafenib) and Mekinist (trametinib), for patients with advanced (metastatic) or unresectable (cannot be removed by surgery) melanoma, the most dangerous type of skin cancer.

Melanoma is the leading cause of death from skin disease. The National Cancer Institute estimates 76,690 Americans will be diagnosed with melanoma and 9,480 will die from the disease in 2013.
Tafinlar, a BRAF inhibitor, is approved to treat patients with melanoma whose tumors express the BRAF V600E gene mutation. Mekinist, a MEK inhibitor, is approved to treat patients whose tumors express the BRAF V600E or V600K gene mutations. Approximately half of melanomas arising in the skin have a BRAF gene mutation. Tafinlar and Mekinist are being approved as single agents, not as a combination treatment.

The FDA approved Tafinlar and Mekinist with a genetic test called the THxID BRAF test, a companion diagnostic that will help determine if a patient’s melanoma cells have the V600E or V600K mutation in the BRAF gene.

“Advancements in our understanding of the biological pathways of a disease have allowed for the development of Tafinlar and Mekinist, the third and fourth drugs the FDA has approved for treating metastatic melanoma in the past two years,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.

Zelboraf (vemurafenib) and Yervoy (ipilimumab) were approved in 2011 for the treatment of metastatic or unresectable melanoma.

“The co-approval of Tafinlar and Mekinist and the second companion diagnostic for BRAF mutation detection demonstrates the commitment of pharmaceutical and diagnostic partners to develop products that detect and target the molecular drivers of cancer,” said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostic Devices and Radiological Health in the FDA’s Center for Devices and Radiological Health.

The FDA’s approval of the THxID BRAF test is based on data from clinical studies that support the Tafinlar and Mekinist approvals. Samples of patients’ melanoma tissue were collected to test for the mutation.

Tafinlar was studied in 250 patients with BRAF V600E gene mutation-positive metastatic or unresectable melanoma. Patients were randomly assigned to receive Tafinlar or the chemotherapy drug dacarbazine. Patients who took Tafinlar had a delay in tumor growth that was 2.4 months later than those receiving dacarbazine.

The most serious side effects reported in patients receiving Tafinlar included an increased risk of skin cancer (cutaneous squamous cell carcinoma), fevers that may be complicated by hypotension (low blood pressure), severe rigors (shaking chills), dehydration, kidney failure and increased blood sugar levels requiring changes in diabetes medication or the need to start medicines to control diabetes.

The most common side effects reported in patients receiving Tafinlar included thickening of the skin (hyperkeratosis), headache, fever, joint pain, non-cancerous skin tumors, hair loss and hand-foot syndrome.

Mekinist was studied in 322 patients with metastatic or unresectable melanoma with the BRAF V600E or V600K gene mutation. Patients were randomly assigned to receive either Mekinist or chemotherapy. Patients receiving Mekinist had a delay in tumor growth that was 3.3 months later than those on chemotherapy. Patients who previously used Tafinlar or other inhibitors of BRAF did not appear to benefit from Mekinist.

The most serious side effects reported in patients receiving Mekinist included heart failure, lung inflammation, skin infections and loss of vision. Common side effects included rash, diarrhea, tissue swelling (peripheral edema) and skin breakouts that resemble acne.

Women of child bearing years should be advised that Tafinlar and Mekinist carry the potential to cause fetal harm. Men and women should also be advised that Tafinlar and Mekinist carry the potential to cause infertility.

Tafinlar and Mekinist are marketed by GlaxoSmithKline, based in Research Triangle Park, N.C. The THxID BRAF Kit is manufactured by bioMérieux of Grenoble, France. Yervoy is marketed by New York City-based Bristol-Myers Squibb, and Zelboraf is marketed by South San Francisco-based Genentech, a member of the Roche Group.

For more information:

FDA: Office of Hematology and Oncology Products 

FDA: Office of In Vitro Diagnostics and Radiological Health  

FDA: Approved Drugs: Questions and Answers 

FDA: Drug Innovation 

NCI: Melanoma 

CDC: Skin Cancer 

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.


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