The FDA has approved Roche’s 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 (sBLA) for Tecentriq was granted under priority review.
The review was also conducted under Project Orbis, an initiative of the FDA Oncology Centre of Excellence that provides a framework for concurrent submission and review of oncology products among international partners.
The approval is based on results from the Phase III IMspire150 study, in which the addition of Tecentriq to Cotellic and Zelboraf helped people live longer without disease worsening or death compared to placebo plus Cotellic and Zelboraf.
“When receiving a cancer immunotherapy combined with targeted therapies, patients with BRAF V600 mutation-positive advanced melanoma were able to live for more than 15 months without their disease worsening,” said Levi Garraway, Genentech’s chief medical officer and head of Global Product Development.
“Today’s FDA approval of this Tecentriq combination represents an important step forward for many patients living with advanced melanoma.”