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# Panel Backs Tecentriq Continued Accelerated Approval
- URL: https://www.fdaweb.com/panel-backs-tecentriq-continued-accelerated-approval/
- Published: 2021-04-28T12:00:00.000Z
- Updated: 2026-09-14T16:56:45.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149203

FDA’s Oncologic Drugs Advisory Committee has voted 7 to 2 to recommend the continuance of Genentech’s accelerated approval for Tecentriq (atezolizumab) plus nab-paclitaxel for treating treat patients with unresectable, locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1\. The panel review is part of an ongoing agency review of accelerated approvals that failed to produce subsequent confirmatory evidence of effectiveness.

The indication gained accelerated approval in 2019 based on progression-free survival data. Additional confirmatory trial data (IMpassion131) have failed to show a statistically significant advantage in the intent-to-treat population, according to the agency.

Treating TNBC is an unmet medical need and few therapies exist, Genentech contended, and continuing Tecentriq’s accelerated approval is justified while three ongoing studies produce additional confirmatory data. FDA’s [briefing document](https://www.fda.gov/media/147854/download?ref=fdaweb.com) noted that it was not clear which of the three ongoing trials are sufficiently designed to adequately confirm the drug’s benefit.

FDA has not said when it will make its final decision on atezolizumab’s continued accelerated approval.