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# Genentech BLA for Lung Cancer Given Priority Review
- URL: https://www.fdaweb.com/genentech-bla-for-lung-cancer-given-priority-review/
- Published: 2016-04-11T12:00:00.000Z
- Updated: 2026-09-14T20:53:45.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5135322

> FDA has accepted for priority review a Genentech BLA for atezolizumab for treating patients with locally advanced or metastatic non-small cell lung cancer whose disease expresses the protein PD-L1 (programmed death ligand-1), as determined by an FDA-approved test, and who have progressed on or after platinum-containing chemotherapy. The agency has set a user fee review target date of 10/19.  
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> The submission is based on results from clinical trials including the Phase 2 BIRCH study. A PMA is also under review by FDA for a companion immunohistochemistry test developed by Roche Tissue Diagnostics that is intended to identify appropriate patients to be treated.