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Basel, 27 August 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the company has made the decision to voluntarily withdraw the US accelerated approval for Tecentriq® (atezolizumab) in combination with chemotherapy (Abraxane®, albumin-bound paclitaxel; nab-paclitaxel) for the treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) whose tumours express PD-L1, as determined by a US Food and Drug Administration (FDA)-approved test. Roche made this decision following consultation with the US FDA, based on the agency’s assessment of the current mTNBC treatment landscape and in accordance with the requirements of the accelerated approval programme. This decision only impacts the mTNBC indication in the US. It does not affect other approved indications for Tecentriq in the US and outside the US, including mTNBC. This is not related to any changes in either the efficacy or safety associated with Tecentriq.
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