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

Regulatory approval published by the Food and Drug Administration.

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.

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
TRODELVY is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated 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.	3

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	ER negative, HER2-negative, PR negative	Invasive Breast Carcinoma	Sacituzumab govitecan
Sensitivity (+)	ER positive, HER2-negative	Invasive Breast Carcinoma	Sacituzumab govitecan
Sensitivity (+)	HER2-negative, PR positive	Invasive Breast Carcinoma	Sacituzumab govitecan
Sensitivity (+)	ER positive, HER2-negative, PR positive	Invasive Breast Carcinoma	Sacituzumab govitecan