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Priority Review for Atezolizumab in Combination With Chemotherapy for Small Cell Lung Cancer


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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. 

REFERENCE

1. Horn L, Mansfield AS, Szczesna A, et al: First-line atezolizumab plus chemotherapy in extensive-stage small-cell lung cancer. N Engl J Med. September 25, 2018 (early release online).


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