Positive CHMP opinion for GSK’s Mekinist in metastatic melanoma
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization for UK pharma giant GlaxoSmithKline’s (LSE: GSK) Mekinist (trametinib) for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation. Mekinist is the first cancer treatment that selectively targets the MEK protein kinase, the EMA stated.
Rafael Amado, head of oncology R&D at GSK, said: “This CHMP opinion brings us a step closer to making another personalized medicine available for patients with BRAF-mutant metastatic melanoma in Europe.”
The CHMP recommendation for trametinib monotherapy is based on a randomized open label Phase III study comparing trametinib to chemotherapy in 322 patients with BRAF mutant melanoma (V600E and V600K) and a non-randomized Phase II study in 97 patients with BRAF mutant melanoma split in two cohorts: previously treated or not treated with a BRAF inhibitor.
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