Posted by Michael Wonder on 19 Feb 2020
FDA grants priority review to Genentech’s Tecentriq monotherapy as first-line treatment of certain people with advanced non-small cell lung cancer
18 February 2020 - Genentech today announced that the U.S. FDA has accepted the company’s supplemental biologics license application and granted priority review for Tecentriq (atezolizumab) as a first-line monotherapy for people with advanced non-squamous and squamous non-small cell lung cancer without EGFR or ALK mutations with high PD-L1 expression, as determined by PD-L1 biomarker testing.
The FDA is expected to make a decision on approval by 19 June 2020.
This application is based on results from the Phase III IMpower110 study, which showed that Tecentriq monotherapy improved overall survival by 7.1 months compared with chemotherapy.
