FDA Approves Two Melanoma Drugs with Diagnostic Test

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The FDA announced the approval of GlaxoSmithKline's two new drugs, Tafinlar (dabrafenib) and Mekinist (trametinib), for patients with metastatic or unresectable melanoma. In addition, the FDA has approved bioMérieux's THxID BRAF test, a companion diagnostic genetic test that will help determine if a patient's melanoma cells have the V600E or V600K mutation in the BRAF gene.

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Tafinlar is a BRAF inhibitor approved to treat patients with melanoma whose tumors express the BRAF V600E gene mutation. Mekinist is a MEK inhibitor approved to treat patients whose tumors express the BRAF V600E or V600K gene mutations.

Tafinlar was studied in 250 patients with BRAF V600E gene mutation-positive metastatic or unresectable melanoma. Patients were randomzied to 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 (DTIC-Dome; Bayer).

Mekinist was studied in 322 patients with metastatic or unresectable melanoma with the BRAF V600E or V600K gene mutation. Patients were randomized to 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 approval of the THxID BRAF test is based on clinical data that support the Tafinlar and Mekinist approvals. Samples of patients' melanoma tissue were collected to test for the mutation.

For more information call (888) 825 5249 or visit GSK.com.

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