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/2026/761115s064lbl.pdf. Revised June 2026. Accessed October 13, 2026.

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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
TRODELVY is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated, in combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph, for the first-line treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 [Combined Positive Score (CPS >= 10)] as determined by an FDA-authorized test. 1

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Organizations
Biomarkers
Cancer types
Therapies
Organizations Biomarkers Cancer types Therapies
FDA (1) ER negative, HER2-negative, PR negative Invasive Breast Carcinoma Sacituzumab govitecan
FDA (1) ER positive, HER2-negative Invasive Breast Carcinoma Sacituzumab govitecan
FDA (1) HER2-negative, PR positive Invasive Breast Carcinoma Sacituzumab govitecan
FDA (1) ER positive, HER2-negative, PR positive Invasive Breast Carcinoma Sacituzumab govitecan
FDA (1) ER negative, HER2-negative, PD-L1 (CPS) >= 10, PR negative Invasive Breast Carcinoma Pembrolizumab, Sacituzumab govitecan