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# Priority Review for Genentech Tecentriq sBLA
- URL: https://www.fdaweb.com/priority-review-for-genentech-tecentriq-sbla/
- Published: 2018-12-05T12:00:00.000Z
- Updated: 2026-09-15T00:48:42.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142972

FDA has accepted a Genentech sBLA for its Tecentriq (atezolizumab) and will give it priority review for a new indication for initial treatment, in combination with carboplatin and etoposide, of people with extensive-stage small cell lung cancer. The agency is expected to make a decision by 3/18/19.

Genentech [says](https://www.marketwatch.com/press-release/fda-grants-priority-review-to-genentechs-tecentriq-in-combination-with-chemotherapy-for-the-initial-treatment-of-extensive-stage-small-cell-lung-cancer-2018-12-05?ref=fdaweb.com) the sBLA is based on results from the Phase 3 IMPower 133 study that met its co-primary endpoints of overall survival and progression-free survival in the initial treatment of people with extensive-stage small cell lung cancer. No new safety signals were identified in the trial, the company says.

Tecentriq is currently approved by FDA to treat people with metastatic non-small cell lung cancer who have disease progression during or following platinum-containing chemotherapy, and who have progressed on an appropriate FDA-approved targeted therapy if their tumor has ALK or EGFR gene abnormalities.

The biologic is described as a monoclonal antibody designed to bind with the PD-LI protein expressed on tumor cells and tumor-infiltrating immune cells, blocking its interaction with both PD-1 and B7.1 receptors.