Posted by Michael Wonder on 05 Dec 2018
FDA grants priority review to Genentech’s Tecentriq in combination with chemotherapy for the initial treatment of extensive-stage small cell lung cancer
4 December 2018 - Genentech today announced that the U.S. FDA has accepted the company’s supplemental biologics license application and granted priority review for Tecentriq (atezolizumab), in combination with carboplatin and etoposide, for the first-line treatment of people with extensive-stage small cell lung cancer (ES-SCLC).
The FDA is expected to make a decision on approval by 18 March 2019.
The application is based on results from the Phase III IMpower133 study, which met its co-primary endpoints of overall survival and progression-free survival in the initial treatment of people with ES-SCLC. The safety profile of the combination was consistent with the safety profiles of the individual medicines, and no new safety signals were identified.
