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FDA Grants Genentech’s Checkpoint Inhibitor Tecentriq Another NSCLC Approval

May 19, 2020

Via: BioSpace

Genentech, a Roche company, announced that the U.S. Food and Drug Administration (FDA) had approved its checkpoint inhibitor Tecentriq (atezolizumab) for first-line treatment for metastatic non-small cell lung cancer (NSCLC) with high PD-L1 expression. An accompanying FDA-approved diagnostic test is used to determine PD-L1 status.

The approval was based on interim analysis from the company’s Phase III IMpower110 trial. It demonstrated that Tecentriq alone improved overall survival (OS) by 7.1 months compared to chemotherapy in patients with high PD-L1 levels. The safety signals were consistent to what was otherwise known about use of the drug, with no new safety signals.

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