- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion supporting the approval of Novartis' (NVS -1.1%) Tafinlar (dabrafenib) and Mekinist (trametinib) for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation. A final decision by the European Commission usually takes ~60 days. The FDA has granted Priority Review for the same patient population.
- The combination has been cleared in the U.S. since January 2014 for the treatment of BRAF V600E/K mutation-positive unresectable or metastatic melanoma.