Pharma Focus Asia

U.S. FDA Approves Trodelvy® in Pre-treated HR+/HER2- Metastatic Breast Cancer

Saturday, February 04, 2023

Gilead Sciences announced the U.S. Food and Drug Administration (FDA) has approved Trodelvy® (sacituzumab govitecan-hziy) 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 earlier 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 also recommended as a Category 1, preferred treatment for metastatic HR+/HER2- breast cancer by the National Comprehensive Cancer Network® (NCCN®) as defined in the Clinical Practise Guidelines in Oncology (NCCN Guidelines®).

Trodelvy improves survival in both pre-treated hr+/her2- metastatic breast cancer and in second-line metastatic triple-negative breast cancer. Trodelvy approval is significant for the breast cancer community.

Trodelvy provides new hope for people living with pre-treated HR+/HER2- metastatic breast cancer, building on the transformative role that Trodelvy is already playing for people with metastatic triple-negative breast cancer.

Trodelvy significantly improves additional secondary endpoint measures, including objective response rate and time to deterioration (TTD) assessed by the Global Health Status/Quality of Life and Fatigue scale per EORTC-QLQ-C30. No statistically significant difference in TTD in Pain Scale were observed.

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