Roche announced that the company is voluntarily withdrawing the U.S. indication for Tecentriq (atezolizumab) in prior platinum-treated metastatic urothelial carcinoma (mUC, bladder cancer), according to a news release.
Roche said the decision was made in consultation with the U.S. Food and Drug Administration (FDA) as part of an industrywide review of accelerated approvals with confirmatory trials that have not met their primary endpoint(s) and have yet to gain regular approvals. Roche said it will work with the FDA over the coming weeks to complete the withdrawal process. This decision does not affect other approved indications for Tecentriq, the company said. Roche is notifying healthcare professionals about this withdrawal.
Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development, said, “While the withdrawal of Tecentriq for priorplatinum 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's Accelerated Approval Program allows conditional approval of a medicine that fills an unmet medical need for a serious condition, with specific post marketing requirements (PMRs) to confirm the clinical benefit and convert to regular approval.
