CHMP recommends Tafinlar (GSK) for treatment of BRAF V600 Metastatic Melanoma
On 27 June 2013, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Tafinlar, 50 and 75 mg capsules, hard, from GSK and intended for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation Metastatic Melanoma.
The active substance of Tafinlar is dabrafenib, a protein kinase inhibitor (L01XE23) that inhibits BRAF kinases with activating codon 600 mutations. The benefits with Tafinlar are its ability to delay the progression of disease and to improve the response rate.
The drug was FDA approved in May 2013.
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