ARTICLE | Company News
Genentech's cobimetinib NDA gets Priority Review
February 20, 2015 2:18 AM UTC
The Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) said FDA accepted for filing and granted Priority Review to an NDA for MEK inhibitor cobimetinib in combination with the marketed BRAF inhibitor Zelboraf vemurafenib to treat metastatic melanoma in patients with BRAF V600 mutations. The PDUFA date is Aug. 11.
The NDA was based on results of the Phase III coBRIM trial, in which cobimetinib plus Zelboraf increased progression free survival (PFS) to 9.9 months vs. 6.2 months for Zelboraf alone (p<0.0001) (see BioCentury Extra, Dec. 15, 2014). ...