Novartis Receives FDA Approval for Trodelvy in HR-Positive HER2-Negative Breast Cancer

Novartis today announced that the FDA has approved Trodelvy (sacituzumab govitecan-hziy) for adults with unresectable locally advanced or metastatic hormone receptor-positive, HER2-negative breast cancer who have received endocrine-based therapy and at least two additional systemic therapies. In the Phase 3 TROPiCS-02 trial, Trodelvy demonstrated a statistically significant improvement in overall survival compared to chemotherapy. The median OS was 14.4 months for Trodelvy versus 11.2 months for chemotherapy. This approval expands Trodelvy's use into HR-positive HER2-negative breast cancer.