The Fly

Gilead announces FDA approves Trodelvy in pre-treated HR+/HER2- breast cancer

Gilead Sciences announced the U.S. FDA has approved Trodelvy for the treatment of adult patients with unresectable locally advanced or metastatic hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting. The approval is based on statistically significant and clinically meaningful progression-free survival and overall survival data from the Phase 3 TROPiCS-02 study. Trodelvy is now also recommended as a Category 1, preferred treatment for metastatic HR+/HER2- breast cancer by the National Comprehensive Cancer Network as defined in the Clinical Practice Guidelines in Oncology. In the TROPiCS-02 study, Trodelvy demonstrated a statistically significant and clinically meaningful overall survival benefit of 3.2 months versus comparator single-agent chemotherapy. Trodelvy also demonstrated a 34% reduction in risk of disease progression or death.

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