Tafinlar now approved for metastatic melanoma in Europe

UK pharma giant GlaxoSmithKline’s (LSE: GSK) Tafinlar (dabrafenib) has been cleared for marketing by the European Medicines Agency as monotherapy for the treatment of adult patients with melanoma that cannot be removed by surgery (unresectable) or that has spread to other parts of the body (metastatic) with a mutated BRAF protein – specifically the BRAF V600 genetic mutation.

This adds to the recent approval of Tafinlar by the US Food and Drug Administration, which also cleared another GSK melanoma drug, Mekinist (trametinib), to treat patients whose tumors express the BRAF V600E or V600K gene mutations (The Pharma Letter May 30).

Will enter a market forecast to grow to $1.5 billion in major markets by 2020