FDA Approves Two Drugs, Companion Diagnostic Test for Advanced Skin Cancer


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The U.S. Food and Drug Administration (FDA) recently approved two new drugs, dabrafenib (Tafinlar) and trametinib (Mekinist), for patients with advanced or unresectable melanoma.

Dabrafenib, a BRAF inhibitor, is approved to treat patients with melanoma whose tumors express the BRAF V600E gene mutation (see page 63 in this issue). Trametinib, a MEK inhibitor, is approved to treat patients whose tumors express the BRAF V600E or V600K gene mutations (see page 78). Approximately half of melanomas arising in the skin have a BRAF gene mutation. Dabrafenib and trametinib were approved as single agents, not as a combination treatment.

Companion Diagnostic

The FDA approved dabrafenib and trametinib 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 2 years,” said Richard Pazdur, MD, Director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. Vemurafenib (Zelboraf) and ipilimumab (Yervoy) were approved in 2011 for the treatment of metastatic or unresectable melanoma. ■


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