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Roche Reports Accelerated FDA Approval Of Tecentriq Combination - Quick Facts

Roche (RHHBY.PK) announced the US FDA has granted accelerated approval to Tecentriq (atezolizumab) plus chemotherapy for the treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer in people whose tumours express PD-L1, as determined by an FDA-approved test. The indication is approved under accelerated approval based on progression-free survival. The company noted that the continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Separately, Roche announced US FDA approval of the VENTANA PD-L1 Assay as the first companion diagnostic to aid in identifying triple-negative breast cancer patients eligible for treatment with the Roche cancer immunotherapy Tecentriq (atezolizumab) plus chemotherapy.

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