Home » Roche’s Tecentriq, Cotellic and Zelboraf Combo Approved for Advanced Melanoma
Roche’s Tecentriq, Cotellic and Zelboraf Combo Approved for Advanced Melanoma
Drugs Submissions and Approvals
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.