Roche: voluntary withdrawal of an indication for Tecentriq
(CercleFinance.com) - Roche has announced that, in consultation with the US FDA, it is voluntarily withdrawing the US indication for Tecentriq (atezolizumab) in metastatic urothelial carcinoma (bladder cancer) prior to platinum treatment.
This decision is part of an industry-wide review of accelerated approvals, whose confirmatory trials have not met their primary endpoints and which have not yet received regular approvals.
The Swiss pharmaceutical company will work with the FDA in next few weeks to complete the withdrawal process. This decision does not affect other approved indications for Tecentriq.
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This decision is part of an industry-wide review of accelerated approvals, whose confirmatory trials have not met their primary endpoints and which have not yet received regular approvals.
The Swiss pharmaceutical company will work with the FDA in next few weeks to complete the withdrawal process. This decision does not affect other approved indications for Tecentriq.
Copyright (c) 2021 CercleFinance.com. All rights reserved.