Roche’s Tecentriq, Cotellic and Zelboraf Combo Approved for Advanced Melanoma

The FDA has approved Roche’s Tecentriq (atezolizumab) in combination with Cotellic (cobimetinib) and Zelboraf (vemurafenib) for the treatment of BRAF V600 mutation-positive advanced melanoma.

The approval was based on results of a phase 3 study, in which the combination treatment helped patients live longer without disease progression or death compared to a placebo plus Cotellic and Zelboraf.

The FDA has granted the combination treatment a priority review and evaluated it under Project Orbis, in which the agency reviews oncology products developed with international partners.