FDA taps the brakes on Genentech's cobimetinib review

The FDA has opted to delay its review of cobimetinib in order to give regulators more time to consider additional Phase III data provided by Genentech. The move pushes back the FDA's PDUFA deadline from August 11 to November 11. Genentech licensed the MEK inhibitor from Exelixis, which holds co-promotion rights in the U.S. Genentech found that a combination of cobimetinib and Zelboraf produced a significant response among melanoma patients, charting a median PFS of 9.9 months compared to 6.2 months on Zelboraf. Exelixis needs a win here. Its key drug cabozantinib failed in a key study for prostate cancer last fall, spurring severe cutbacks at the biotech. Release