Genentech, a member of Swiss drug maker Roche Group (RHHBY) said Wednesday that the U.S. Food and Drug Administration or FDA has accepted the company’s supplemental Biologics License Application (sBLA) and granted Priority Review for Tecentriq (atezolizumab) as a first-line monotherapy for certain people with advanced non-small cell lung cancer.
The FDA approval is for people with advanced non-squamous and squamous non-small cell lung cancer or NSCLC 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 Tecentriq’s approval by June 19, 2020.
This sBLA is based on results from the Phase III IMpower110 study, which showed that Tecentriq monotherapy improved overall survival or OS by 7.1 months compared with chemotherapy. Safety for Tecentriq appeared to be consistent with its known safety profile, and no new safety signals were identified.
Genentech said it has an extensive development program for Tecentriq, including multiple ongoing and planned Phase III studies across lung, genitourinary, skin, breast, gastrointestinal, gynecological and head and neck cancers. This includes studies evaluating Tecentriq both alone and in combination with other medicines.
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