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# Roche Withdraws Tecentriq Bladder Cancer Indication
- URL: https://www.fdaweb.com/roche-withdraws-tecentriq-bladder-cancer-indication/
- Published: 2022-11-29T12:00:00.000Z
- Updated: 2026-09-14T18:07:48.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153278

Roche says it is withdrawing a Tecentriq (atezolizumab) accelerated approval indication for treating adults with locally advanced or metastatic urothelial carcinoma (bladder cancer) who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 or are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. Roche says it made the decision after consulting with FDA on a Phase 3 confirmatory study (IMvigor130) that failed to meet the co-primary endpoint of overall survival for Tecentriq plus chemotherapy compared with chemotherapy alone.

This is the second Tecentriq indication withdrawn in three months. In August, Roche decided to withdraw the accelerated approval for Tecentriq in combination with chemotherapy (Abraxane, albumin-bound paclitaxel; nab-paclitaxel) for treating adults with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) whose tumors express PD-L1\. The decision, which only affects the mTNBC indication in the U.S., was encouraged by FDA based on its assessment of the current mTNBC treatment landscape, the company said at the time.

Tecentriq was given accelerated approval for the mTNBC indication 3/2019\. A confirmatory study did not meet its primary endpoint of progression-free survival for first-line treatment of mTNBC. In April, an FDA advisory committee reviewed the data and voted 7 to 2, recommending the continued accelerated approval ([see earlier story](https://www.fdaweb.com/panel-backs-tecentriq-continued-accelerated-approval/)). “However, due to the recent changes in the treatment landscape, the FDA no longer considers it appropriate to maintain the accelerated approval,” Roche says. Earlier this year, FDA granted Gilead Sciences full approval for Trodelvy (sacituzumab govitecan-hziy) for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer.

The latest withdrawal does not affect other approved indications for Tecentriq, Roche says. The therapy is currently approved for treating non-small cell lung cancer, small cell lung cancer, liver cancer, and melanoma.