The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the combination of two Novartis’ drugs for treating melanoma, Tafinlar (dabrafenib) and Mekinist (trametinib). The drugs were recommended for approval for treating adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation. The US Food and Drug Administration (FDA) also has granted priority review for the same patient population.

The European Commission will review the CHMP recommendation and is expected to deliver its final decision within three months. The decision will be applicable to all 28 European Union member states plus Iceland, Norway, and Liechtenstein.

Novartis acquired Tafinlar and Mekinist earlier this year as part of its three-part transaction with GlaxoSmithKline (GSK), under which Novartis acquired certain oncology products and pipeline compounds from GSK, created a consumer healthcare joint venture that combined the two companies’ consumer healthcare divisions, and divested its non-influenza vaccines business to GSK.

In 2014, the US Food and Drug Administration (FDA) approved the combination of the two drugs for treating patients with BRAF V600E/K mutation-positive unresectable or metastatic melanoma as detected by an FDA-approved test. The combination was approved through the FDA’s accelerated approval program and reviewed under a priority review designation. The approval was contingent on the results of a clinical study designed to evaluate the clinical benefit of the combination in patients with unresectable or metastatic melanoma with a BRAF V600 mutation. The FDA target action date is in November 2015. In May 2013, the FDA approved both drugs as single agents to treat patients with unresectable or metastatic melanoma.

Source: Novartis