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US FDA Approves Sacituzumab Govitecan In Pre-treated HR+/HER2- Metastatic Breast Cancer

The U.S. Food and Drug Administration (FDA) has approved sacituzumab govitecan-hziy (Trodelvy®; Gilead Sciences) for the treatment of adult patients with unresectable locally advanced 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.

Sacituzumab Govitecan Demonstrates Clinical Efficacy Across Trop-2 Expression Levels in HR+/HER2-...

Results from a post-hoc analysis from the Phase 3 TROPiCS-02 study evaluating sacituzumab govitecan-hziy (Trodelvy®; Gilead Sciences) versus comparator chemotherapy (physicians’ choice of chemotherapy, TPC) in patients...
Featured Image: Women and the power to fight breast cancer Courtesy: © 2017. Fotolia. Used with permission.

FDA Accepts for Priority Review of sBLA for Gilead’s Sacituzumab Govitecan...

The U.S. Food and Drug Administration (FDA) has accepted for priority review the supplemental Biologics License Application (sBLA) for sacituzumab govitecan-hziy (Trodelvy®; Gilead Sciences)...

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