Therapeutic Response Statement (Sensitivity)

This therapeutic response statement Supports the relationship that ER negative, HER2-negative, and PR negative status confers therapeutic sensitivity to Sacituzumab govitecan in patients with Invasive Breast Carcinoma.

The U.S. Food and Drug Administration granted approval to sacituzumab govitecan for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease.

This statement is based on a regulatory approval from the Food and Drug Administration:

TRODELVY is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease.

Citation

Gilead Sciences, Inc. Trodelvy (sacituzumab govitecan) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761115s035lbl.pdf. Revised February 2023. Accessed October 30, 2024. Gilead Sciences, Inc. Trodelvy (sacituzumab govitecan) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761115s005s013lbl.pdf. Revised April 2021. Accessed October 6, 2026.

Contributions

Date	Contributor	Description
2024-10-30	Van Allen lab	Initial access of FDA approvals
2021-04-07	Food and Drug Administration	Indication received traditional approval.