FDA approves two GSK melanoma drugs and bioMerieux companion diagnostic

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.