EMA validates MAA for Trodelvy for pre-treated HR+/HER2- metastatic breast cancer
Gilead Sciences, Inc. announced that the European Medicines Agency (EMA) has validated a Type II variation Marketing Authorization Application (MAA) for Trodelvy (sacituzumab govitecan-hziy) for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-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
This Marketing Authorization Application is based on data from the registrational Phase III TROPiCS-02 study, which met its primary endpoint of progression-free survival (PFS) and key secondary endpoint of overall survival (OS) versus comparator chemotherapies (treatment of physician’s choice (TPC) of chemotherapy). PFS data were published in the Journal of Clinical Oncology (previously cited),and OS data were recently presented at ESMO Congress 2022.
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