Roche announces the FDA has granted Priority Review for Tecentriq

Roche has announced that the FDA has granted Priority Review for Tecentriq® (atezolizumab), in combination with carboplatin and etoposide, for the initial treatment of people with extensive-stage small cell lung cancer. The decision was made in light of Roche’s supplemental Biologics License Application which is based on the Phase III IMpower133 study results which met its co-primary endpoints of overall survival (12.3 months vs. 10.3 months) and progression-free survival (5.2 months vs. 4.3 months) with the combination versus chemotherapy alone. The one year overall survival rate for patients treated with the combination was 51.7% versus 38.2% for patients treated with chemotherapy alone. The one year progression-free survival rate for patients treated with the combination was 12.6% vs. 5.4% for patients treated with chemotherapy alone. The safety profile of the combination was consistent with the safety profiles of the individual medicines, and no new safety signals were identified.

Sandra Horning, MD, Chief Medical Officer and Head of Global Product Development at Roche, said: “It’s been more than 20 years since there has been a new initial treatment option for extensive-stage small cell lung cancer that delivers a clinically meaningful survival benefit. We are working closely with the FDA to bring this Tecentriq-based regimen to people with this difficult-to-treat type of lung cancer as soon as possible.”