European CHMP Adopts Positive Opinion for Cobimetinib in Combination with Vemurafenib for the Treatment of Advanced Melanoma

Exelixis, Inc.

today announced that the European Medicines Agency's Committee for Medical Products for Human Use (CHMP) has adopted a positive opinion of the Marketing Authorization Application for cobimetinib, a selective MEK inhibitor discovered by Exelixis, in combination with vemurafenib for the treatment of BRAF V600 mutation-positive unresectable or metastatic melanoma. The CHMP's positive opinion will now be reviewed by the European Commission, which has the authority to approve medicines for the European Union. The European Commission is expected to release its final decision regarding the approval of the combination of cobimetinib and vemurafenib by the end of 2015. "The CHMP's positive opinion on cobimetinib for use in combination with vemurafenib is an important milestone in bringing this new therapeutic option to patients in Europe," said Michael M. Morrissey, Ph.D., president and chief executive officer of Exelixis. "We congratulate Genentech and Roche on this latest milestone in the European regulatory process. We also look forward to the regulatory decision anticipated this year in the United States, where we are fully prepared to co-promote cobimetinib with our partners." The CHMP's recommendation is based on data from coBRIM, the international, randomized double-blind controlled phase 3 pivotal trial evaluating cobimetinib in combination with vemurafenib in previously untreated patients with unresectable locally advanced or metastatic melanoma harboring a BRAF V600 mutation. The combination of cobimetinib and vemurafenib recently received its first approval in Switzerland, where cobimetinib is marketed as Cotellic(TM). The coBRIM trial was conducted by Roche and Genentech, a member of the Roche Group. Genentech filed a New Drug Application (NDA) for cobimetinib in the United States, for which the Prescription Drug User Fee Act action date is November 11, 2015.