Market Overview

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


Exelixis, Inc. (NASDAQ: EXEL) 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
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.

Posted-In: News Press Releases


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