SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--
Yesterday, Exelixis’ (EXEL) partner Genentech, a member of the Roche Group, informed Exelixis that, in order to accommodate its review of a supplemental data submission, the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) action date for its review of Genentech’s New Drug Application (NDA) for cobimetinib by the standard extension period of three months, from August 11, 2015 to November 11, 2015.
FDA extended its review after Genentech submitted, at FDA request, additional data from coBRIM, the phase 3 registrational trial of cobimetinib and vemurafenib in patients with BRAF V600 mutation-positive advanced melanoma.
Exelixis discovered cobimetinib, a selective inhibitor of MEK, internally and advanced the compound to investigational new drug (IND) status. In late 2006, ExelixisRead More »from Exelixis Provides Update on Genentech’s Pending New Drug Application for Cobimetinib, an Exelixis-Discovered Compound