FDA accepts and grants priority review for Genentech's cobimetinib/Zelboraf

Genentech, part of the Roche Group (ROG: SIX), says that the US Food and Drug Administration has accepted and granted priority review for its New Drug Application for cobimetinib in combination with Zelboraf (vemurafenib) in BRAF V600 mutation-positive advanced melanoma.

The FDA will make its decision as to whether to approve the therapy by August 11, 2015.

Sandra Horning, chief medical officer and head of global product development, said: "We are pleased the FDA has accepted our application for cobimetinib in combination with Zelboraf and granted it Priority Review status. We look forward to working with the FDA to bring this new treatment option to people with BRAF mutation-positive advanced melanoma as soon as possible."