Genentech has completed an NDA filing with FDA for cobimetinib for treatment, in combination with Zelboraf (vemurafenib), for people with BRAF V600 mutation-positive advanced melanoma.
In a Phase III coBRIM study, published in the New England Journal of Medicine, the MEK inhibitor cobimetinib used with Zelboraf reduced by half the risks of the disease worsening or death, with a median progression-free survival of 9.9 months, compared with 6.2 months with Zelboraf alone.
Genentech owner Roche submitted a marketing authorization application for the combination to the European Medicines Agency in September.
