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The decision by Roche comes shortly after AstraZeneca withdrew the bladder cancer indication for durvalumab (Imfinzi).
One month after AstraZeneca made a similar decision, Roche is voluntarily withdrawing its US indication for atezolizumab (Tecentriq) for prior-platinum treated metastatic urothelial carcinoma (mUC) or bladder cancer.
The decision was made in consultation with FDA as part of an industrywide review of accelerated approvals with confirmatory trials that have not met their primary endpoint and have yet to gain regular approvals, Roche said in a press release.
Tecentriq had nearly $3 billion in sales in 2020, Reuters reported.
In February, AstraZeneca voluntarily withdrew durvalumab’s (Imfinzi) indication for locally advanced or metastatic bladder cancer.
“The Accelerated Approval Program allows people with difficult-to-treat cancers to receive certain new therapies earlier,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of global product development at Roche. “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.”
FDA's Accelerated Approval Program allows conditional approval of a medication that fills an unmet medical need for a serious condition, with specific post-marketing requirements (PMRs) to confirm the clinical benefit.
FDA granted Tecentriq accelerated approval in 2016 to treat prior-platinum treated mUC based on the results from the IMvigor210 study. Continued approval for this indication was contingent upon the results of IMvigor211, the original PMR for the prior-platinum treated mUC indication, Roche said.
However, that study did not meet its primary endpoint of overall survival in the PD-L1 high patient population, according to Roche.