Atezolizumab Indication in US Withdrawn for Previously Treated Metastatic Urothelial Cancer

As part of an industry-wide assessment of indications based on accelerated approval, Roche in consultation with the FDA has decided to withdraw the indication for atezolizumab in patients with urothelial carcinoma following platinum-based chemotherapy.

The indication for atezolizumab (Tecentriq) in patients with urothelial carcinoma who have previously received platinum-based chemotherapy has been withdrawn in the United States, according to the drug’s developer, Roche.1

The decision was made in consultation with the FDA and is part of an industry-wide assessment of indications from accelerated approval that have not met requirements of confirmation. The decision to withdraw the agent for use in this patient population does not affect indications for atezolizumab in other diseases.

“The Accelerated Approval Program allows people with difficult-to-treat cancers to receive certain new therapies earlier,” Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development, said in a press release. “While the withdrawal of Tecentriq for prior-platinum treated bladder cancer is disappointing, Tecentriq continues to demonstrate benefits across multiple cancer types and therefore remains a meaningful treatment option for many patients.”

The FDA initially granted accelerated approval for the indication back in 2016 for patients who have disease progression during or following platinum-based chemotherapy, or whose disease has worsened within 12 months of receiving platinum-based neoadjuvant or adjuvant chemotherapy.2

Accelerated approval was based on results of the phase 2 IMvigor210 trial (NCT02108652), which showed promising responses in patients receiving second-line atezolizumab versus historical controls.3

Continued approval was contingent upon the results of the phase 3 IMvigor211 trial (NCT02302807), which failed to meet its primary end point of overall survival improvement in patients with tumors that express PD-L1 (HR, 0.87; 95% CI, 0.63-1.21; P = .41).4 These results precluded any further statistical analysis of the trial.

The IMvigor130 trial (NCT02807636), a phase 3 trial of atezolizumab as monotherapy or in combination with platinum-based chemotherapy in the frontline setting, will continue as a post marketing requirement until its final analysis. However, with rapid developments in the treatment of second-line disease, Roche believed voluntary withdrawal of the second-line indication was appropriate.

Atezolizumab is an anti–PD-L1 monoclonal antibody which is approved in the United States as therapy for certain indications in non–small cell lung cancer, metastatic triple-negative breast cancer, and hepatocellular carcinoma, small cell lung cancer, and melanoma.


  1. Roche provides update on Tecentriq US indication in prior-platinum treated metastatic bladder cancer. News release. Roche. March 8, 2021. Accessed March 8, 2021.
  2. FDA approves new, targeted treatment for bladder cancer. News release. FDA. May 18, 2016. Accessed March 8, 2021.
  3. Rosenberg JE, Hoffman-Censits J, Powles T, et al. Atezolizumab in patients with locally advanced and metastatic urothelial carcinoma who have progressed following treatment with platinum-based chemotherapy: a single-arm, multicentre, phase 2 trial. Lancet. 2016;387(10031):1909-20. doi: 10.1016/S0140-6736(16)00561-4
  4. Powles T, Durán I, van der Heijden MS, Loriot Y, Vogelzang NJ, De Giorgi U, Oudard S, Retz MM, Castellano D, Bamias A, et al. Atezolizumab versus chemotherapy in patients with platinum-treated locally advanced or metastatic urothelial carcinoma (IMvigor211): a multicentre, open-label, phase 3 randomised controlled trial. Lancet. 2018;391(10122):748-757. doi: 10.1016/S0140-6736(17)33297-X