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AUGUST 4, 2020

FDA Grants New Indication for Tecentriq Plus Cotellic and Zelboraf for Advanced Melanoma

The FDA granted a new indication for atezolizumab (Tecentriq, Genentech) to be used with cobimetinib (Cotellic, Genentech) and vemurafenib (Zelboraf, Genentech) to treat patients with BRAF V600 mutation–positive advanced melanoma

The supplemental Biologics License Application for atezolizumab was based on results from the phase 3 IMspire150 study, a multicenter, double-blind, placebo-controlled, randomized study in people with previously untreated BRAF V600 mutation–positive