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ARTICLE | Company News

Genentech submits NDA for melanoma combo

December 16, 2014 3:17 AM UTC

The Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) submitted an NDA to FDA for the combination of the MEK inhibitor cobimetinib plus the BRAF inhibitor Zelboraf vemurafenib to treat metastatic melanoma in patients with BRAF V600 mutations.

The submission was based on results from the Phase III coBRIM trial, in which the combination increased PFS to 9.9 months vs. 6.2 months for Zelboraf alone (p<0.0001). OS data were not yet mature as of a September interim analysis, at which time the p-value of 0.046 did not cross the pre-specified boundary for significance. ...