FDAnews
www.fdanews.com/articles/174315-ec-green-lights-exelixis-cotellic-for-metastatic-melanoma

EC Green Lights Exelixis’ Cotellic for Metastatic Melanoma

December 3, 2015

The European Commission has approved Exelixis’ Cotellic for use in combination with vemurafenib for treatment of adults with metastatic melanoma with a BRAF V600 mutation.

The combination is approved by the FDA for the treatment of patients with BRAF V600E or V600K mutation-positive metastatic melanoma. Further country approvals are anticipated in 2016, the company says.