European Medicines Agency Recommends Granting a Marketing Authorisation for Dabrafenib

Dabrafenib is indicated in monotherapy for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation

On 27 June 2013, the European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product dabrafenib (Tafinlar), 50 and 75 mg capsules, hard, intended for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.

The applicant for this medicinal product is GlaxoSmithKline Trading Services Limited. They may request a re-examination of any CHMP opinion, provided they notify the European Medicines Agency in writing of their intention within 15 days of receipt of the opinion.

The active substance of Tafinlar is dabrafenib, a protein kinase inhibitor (L01XE23) that inhibits BRAF kinases with activating codon 600 mutations.

The benefits with dabrafenib are its ability to delay the progression of disease and to improve the response rate.

The most common side effects are hyperkeratosis, headache, pyrexia, arthralgia, fatigue, nausea, papilloma, alopecia, rash and vomiting.

A pharmacovigilance plan for dabrafenib will be implemented as part of the marketing authorisation.

The approved indication is: "Dabrafenib is indicated in monotherapy for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation”.

It is proposed that dabrafenib be initiated and supervised by a qualified physician experienced in the use of anticancer medicinal products.

Detailed recommendations for the use of this product will be described in the summary of product characteristics, which will be published in the European public assessment report and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.

The CHMP, on the basis of quality, safety and efficacy data submitted, considers there to be a favourable benefit-to-risk balance for dabrafenib and therefore recommends the granting of the marketing authorisation.