Tecentriq (atezolizumab) is now approved in combination with 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, according to manufacturer Genentech, a member of the Roche Group.

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 Center 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 their disease worsening or death (progression-free survival, PFS), compared to placebo plus Cotellic and Zelboraf (median PFS 15.1 months versus 10.6 months respectively; hazard ratio, HR=0.78; confidence interval: 0.63-0.97; P=0.025). The most common adverse reactions (rate ≥20 percent) in patients who received Tecentriq plus Cotellic and Zelboraf were rash (75 percent), musculoskeletal pain (62 percent), fatigue (51 percent), hepatotoxicity (50 percent), pyrexia (49 percent), nausea (30 percent), pruritus (26 percent), edema (26 percent), stomatitis (23 percent), hypothyroidism (22 percent), and photosensitivity reaction (21 percent).

Genentech’s development program for Tecentriq includes multiple ongoing and planned Phase 3 studies across lung, genitourinary, skin, breast, gastrointestinal, gynecological and head and neck cancers. This includes studies evaluating Tecentriq both alone and in combination with other medicines.

Genentech will offer patient assistance programs for Tecentriq plus Cotellic and Zelboraf through Genentech Access Solutions.