Genentech files NDA for cobimetinib + Zelboraf at FDA for BRAF V600 mutation positive advanced Melanoma
Genentech, a member of the Roche Group announced the company has submitted a New Drug Application (NDA) for cobimetinib to the FDA for treatment, in combination with Zelboraf (vemurafenib), for people with BRAF V600 mutation-positive advanced melanoma. The submission is based on results of the coBRIM Phase III study, which showed people who received the MEK inhibitor cobimetinib plus Zelboraf lived significantly longer without their disease worsening or death (progression-free survival; PFS) compared to Zelboraf alone.
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