NEW YORK – The European Commission on Thursday approved Gilead Sciences' Trop-2-directed antibody-drug conjugate Trodelvy (sacituzumab govitecan) for advanced, pretreated, hormone receptor-positive, HER2-negative breast cancer patients.
The approval, which follows a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) last month, makes Trodelvy available to patients in the EU who have received prior endocrine-based therapy and two additional systemic therapies.
The regulators based their decision on the results of the Phase III TROPiCS-02 study, in which patients who received Trodelvy lived a median of 14.4 months, versus 11.2 months for patients who received chemotherapy. The US Food and Drug Administration approved Trodelvy for this patient population based on the TROPiCS-02 study in February.
The European Society for Medical Oncology includes Trodelvy as a category I preferred treatment for HR-positive, HER2-negative metastatic breast cancer patients. In the US, the National Comprehensive Cancer Network recommends Trodelvy as a category 1 treatment in this setting.