FDA approves two GSK melanoma drugs and bioMerieux companion diagnostic

30 May 2013

The US Food and Drug Administration yesterday (May 29) approved two new oral drugs from UK pharma giant GlaxoSmithKline (LSE: GSK), Tafinlar (dabrafenib) and Mekinist (trametinib), for patients with metastatic melanoma, the most dangerous type of skin cancer.

Tafinlar, a BRAF inhibitor, is cleared 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 from France’s bioMerieux (Euronext: BIM), that will help determine if a patient’s melanoma cells have the V600E or V600K mutation in the BRAF gene.

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