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# FDA Accepts Genentech sBLA for Tecentriq
- URL: https://www.fdaweb.com/fda-accepts-genentech-sbla-for-tecentriq/
- Published: 2019-01-17T12:00:00.000Z
- Updated: 2026-09-15T00:55:11.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5143177

FDA has accepted for review a Genentech supplemental BLA for Tecentriq (atezolizumab) in combination with Celgene’s Abraxane (albumin-bound paclitaxel; *nab*\-paclitaxel) and carboplatin for the first-line treatment of people with metastatic non-squamous non-small cell lung cancer (NSCLC) who do not have EGFR or ALK genomic tumor aberrations. The agency has set a 9/2 user fee review action target date.

The submission is based on results from the Phase 3 IMpower130 study, which met its co-primary endpoints of overall survival (OS) and progression-free survival (PFS) in the initial treatment of people with metastatic non-squamous NSCLC, the company says. FDA recently approved Tecentriq in combination with Avastin, paclitaxel and carboplatin for the initial treatment of people with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations. Tecentriq is also approved for treating people with metastatic NSCLC who have disease progression during or following platinum-containing chemotherapy.