March 8, 2021

Genentech has voluntarily withdrawn an indication for Tecentriq® (atezolizumab) to treat metastatic urothelial carcinoma (mUC) in patients who have previously received platinum-based therapy for the disease. The withdrawal is based on the results of a confirmatory clinical trial, which was required as a condition of Tecentriq’s accelerated approval for the indication. It does not affect the drug’s other indications.

The U.S. FDA granted accelerated approval for Tecentriq’s prior-platinum treated mUC indication in 2016. Accelerated approvals are based on early clinical data and allow drugs for serious conditions with unmet medical needs to reach patients sooner. Continued approval for the indication is typically based on confirmatory trials designed to verify the drug’s clinical benefit. Tecentriq did not meet a primary endpoint for overall survival in a post-marketing clinical study.

First FDA approved in 2016, Tecentriq is still indicated to treat non-small cell lung cancer, triple-negative breast cancer, small cell lung cancer, hepatocellular carcinoma, and melanoma. It also retains indications to treat urothelial carcinoma in patients who meet certain clinical criteria.

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