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FDA accelerated approval for Tecentriq voluntarily withdrawn in metastatic urothelial carcinoma .- Genentech/Roche

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Published:9th Mar 2021
Genentech/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). This decision was made in consultation with the FDA as part of an industry-wide review of accelerated approvals with confirmatory trials that have not met their primary endpoint(s) and have yet to gain regular approvals. Genentech will work with the FDA over the coming weeks to complete the withdrawal process. This decision does not affect other approved indications for Tecentriq. Genentech is notifying healthcare professionals about this withdrawal. Patients being treated with Tecentriq for prior-platinum treated mUC should discuss their care with their healthcare provider.Tecentriq was granted accelerated approval in 2016 for the treatment of prior-platinum treated mUC based on the results from the IMvigor210 study (Cohort 2). Continued approval for this indication was contingent upon the results of IMvigor211, the original PMR for the prior-platinum mUC indication. This study did not meet its primary endpoint of overall survival in the PD-L1 high patient population. Subsequently, the FDA designated the IMvigor130 study as the PMR which will still continue until the final analysis. However, as the treatment landscape in prior-platinum (second-line) mUC has rapidly evolved with the emergence of new treatment options, Genentech is voluntarily withdrawing this indication in recognition of the principles of the Accelerated Approval Program.
Condition: Bladder Cancer
Type: drug

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