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Based on FDA Review, Manufacturer Withdraws Atezolizumab for Use in Bladder Cancer

By: JNCCN 360 Staff
Posted: Wednesday, March 10, 2021

On March 8, Genentech, a member of the Roche Group, has announced it will voluntarily withdraw the U.S. indication for atezolizumab (Tecentriq) in patients with metastatic urothelial carcinoma who had received prior platinum therapy. The decision is based on the U.S. Food and Drug Administration (FDA) review of drugs that were granted accelerated approval based on small studies whose results were later not confirmed by larger trials. Of note, this decision does not affect other approved indications for atezolizumab in non–small cell lung cancer, small cell lung cancer, certain types of bladder cancer, a type of triple-negative breast cancer, and liver cancer.

Continued approval for this indication for atezolizumab in metastatic urothelial cancer was contingent upon the results of IMvigor211. However, the study failed to meet its primary endpoint of overall survival in the patient population with high expression of PD-L1.

The FDA approved atezolizumab for this indication in bladder cancer in 2016. A later trial required by the FDA failed to show that this agent extended survival for this patient population. This decision by Roche follows within weeks of the voluntary withdrawal of the indication for PD-L1 inhibitor durvalumab (Imfinzi) in previously treated adults with locally advanced or metastatic bladder cancer.



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