The U.S. Food and Drug Administration (FDA) accepted a supplemental biologics license application (sBLA) and granted Priority Review for atezolizumab (Tecentriq) in combination with carboplatin and etoposide for the first-line treatment of patients with extensive-stage small cell lung cancer. The FDA is expected to make a decision on approval by March 18, 2019.
This sBLA is based on results from the phase III IMpower133 study, a multicenter, double-blinded, randomized placebo-controlled study evaluating the efficacy and safety of atezolizumab in combination with carboplatin and etoposide vs carboplatin and etoposide alone in chemotherapy-naive patients with extensive-stage small cell lung cancer.1
IMpower133 met its co-primary endpoints of overall survival and progression-free survival in the initial treatment of people with extensive-stage small cell lung cancer. The safety profile of the combination was consistent with the safety profiles of the individual medicines, and no new safety signals were identified. ■