Cobimetinib regulatory update

FDA extended the PDUFA date by 3 months to Nov. 11 from Aug. 11 for an NDA from Roche’s Genentech unit for cobimetinib plus Zelboraf vemurafenib to treat BRAF V600 mutation-positive advanced melanoma. Exelixis said the review was extended following the submission of additional data from the Phase III coBRIM trial at FDA’s request. Updated data from coBRIM showed the combination increased progression free survival (PFS) to 12.3 months vs. 7.2 months for Zelboraf alone (HR=0.58, 95% CI: 0.46, 0.72) (see BioCentury, June 8). ...