Posted by Michael Wonder on 30 Jul 2020
FDA approves Genentech’s Tecentriq plus Cotellic and Zelboraf for people with advanced melanoma
30 July 2020 - Genentech today announced that the U.S. FDA approved Tecentriq (atezolizumab) plus Cotellic (cobimetinib) and Zelboraf (vemurafenib) for the treatment of BRAF V600 mutation-positive advanced melanoma patients.
The safety profile observed in the Tecentriq combination was consistent with the known safety profiles of the individual medicines.
The supplemental biologics license application for Tecentriq was granted under priority review. The review was also conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence that provides a framework for concurrent submission and review of oncology products among international partners.
