Exelixis: FDA Accepts For Review Genentech NDA For Cobimetinib With Vemurafenib

(RTTNews) - Exelixis, Inc. (EXEL) said the U.S. Food and Drug Administration has accepted for review Genentech's New Drug Application for cobimetinib in combination with vemurafenib for patients with unresectable or metastatic melanoma harboring a BRAF V600 mutation.

Cobimetinib is a specific MEK inhibitor discovered by Exelixis and is now the subject of a worldwide co-development agreement between Exelixis and Genentech, a member of the Roche Group.

FDA has granted priority review to the NDA and assigned a Prescription Drug User Fee Act action date of August 11. A priority review designation is granted to medicines that the FDA determines have the potential to provide significant improvements in the treatment, prevention or diagnosis of a disease.

The NDA is based on data from coBRIM, a phase 3 pivotal trial conducted by Genentech. Roche also submitted a Marketing Authorization Application (MAA) to the European Medicines Agency for the combination of cobimetinib and vemurafenib in 2014.

"The FDA's acceptance of the cobimetinib NDA brings us one step closer to a potential new treatment option for patients with advanced BRAF V600 mutation-positive melanoma, a form of the disease for which new approaches are needed," said Michael Morrissey, president and chief executive officer of Exelixis.