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19-10-2021 | Oncology | News | Article

approvalsWatch

EMA backs sacituzumab govitecan for TNBC

Author:
Hannah Kitt

medwireNews: The EMA has adopted a positive opinion for the use of sacituzumab govitecan in previously treated patients with unresectable or metastatic triple-negative breast cancer (TNBC).

Specifically, the drug is indicated for adults in Europe who have received at least two prior systemic therapies, of which at least one must have been in the advanced setting.

The decision was based on results of the phase 3 ASCENT study, which demonstrated significantly better overall- and progression-free survival with the Trop-2-directed antibody–drug conjugate than physicians’ choice of single-agent chemotherapy. It follows US FDA approval of the drug in the same patient population in 2020.

medwireNews is an independent medical news service provided by Springer Healthcare Ltd. © 2021 Springer Healthcare Ltd, part of the Springer Nature Group

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