Trodelvy (sacituzumab govitecan) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration. Deprecated

Citation

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.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication	Statements
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.	1

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Organizations	Biomarkers	Cancer types	Therapies
FDA (1)	ER negative, HER2-negative, PR negative	Invasive Breast Carcinoma	Sacituzumab govitecan