3 January 2023 - Application based on statistically significant and clinically meaningful overall survival and progression-free survival results from the Phase 3 TROPiCS-02 trial.

Gilead Sciences today announced that the EMA has validated a Type II variation marketing authorisation application for Trodelvy (sacituzumab govitecan-hziy) for the treatment of adult patients with unresectable or metastatic hormone receptor positive, human epidermal growth factor receptor 2 negative (IHC 0, IHC 1+ or IHC 2+/ISH–) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.

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