> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Trodelvy OK’d for Pre-treated Metastatic Breast Cancer
- URL: https://www.fdaweb.com/trodelvy-okd-for-pre-treated-metastatic-breast-cancer/
- Published: 2023-02-03T12:00:00.000Z
- Updated: 2026-09-14T18:14:31.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153699

FDA has approved a Gilead Sciences supplemental BLA for Trodelvy (sacituzumab govitecan-hziy) for treating adult patients with unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting. Approval was based on results from the Phase 3 TROPiCS-02 study that showed “statistically significant and clinically meaningful progression-free survival and overall survival data,” the company says. “Three times as many people treated with Trodelvy were progression free at one year versus those treated with chemotherapy (21% versus 7%).”

Gilead says the therapy’s safety profile in TROPiCS-02 was similar to prior studies, and no new safety signals were identified in the target patient population. The most frequent serious adverse reactions observed in the study were diarrhea (5%), febrile neutropenia (4%), neutropenia (3%), abdominal pain, colitis, neutropenic colitis, pneumonia, and vomiting (each 2%).

Trodelvy was previously approved for treating certain patients with pre-treated HR+/HER2- metastatic breast cancer and it has an accelerated approval for certain patients with second-line metastatic urothelial cancer.