EC OKs Novartis Combo Drug for MelanomaBy
The European Commission has approved Novartis’ combination therapy of Tafinlar (dabrafenib) and Mekinist (trametinib) for treating unresectable or metastatic melanoma with a BRAF V600 mutation. The European Commission approval applies 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 the US, the Food and Drug Administration (FDA) granted priority review in July 2015 for regular approval of the Tafinlar and Mekinist combination in BRAF V600 mutation-positive metastatic melanoma. Since January 2014, the combination of Tafinlar and Mekinist has been approved for use in the US in 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. In May 2013, the FDA approved both drugs as single agents to treat patients with unresectable or metastatic melanoma.