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Roche provides update on Tecentriq US indication in prior-platinum treated metastatic bladder cancer

Written by Customer Service on . Posted in Public Companies.

Basel, 8 March 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the company is voluntarily withdrawing the US indication for Tecentriq® (atezolizumab) in prior-platinum treated metastatic urothelial carcinoma (mUC, bladder cancer). This decision was made in consultation with the US Food and Drug Administration (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. Roche will work with the FDA over the coming weeks to complete the withdrawal process. This decision does not affect other approved indications for Tecentriq. Roche 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.
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