Trodelvy (sacituzumab govitecan) [product information]. EMA.

Regulatory approval published by the European Medicines Agency.

Citation

Gilead Sciences Ireland UC. Trodelvy (sacituzumab govitecan) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/trodelvy-epar-product-information_en.pdf. Revised August 2023. Accessed March 25, 2024.

Regulatory approvals

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

Indication	Statements
Trodelvy as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, including at least one of them for advanced disease.	1
Trodelvy as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer who have received endocrine-based therapy, and at least two additional systemic therapies in the advanced 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 (+)	HER2-negative, PR positive	Invasive Breast Carcinoma	Sacituzumab govitecan
Sensitivity (+)	ER positive, HER2-negative	Invasive Breast Carcinoma	Sacituzumab govitecan
Sensitivity (+)	ER positive, HER2-negative, PR positive	Invasive Breast Carcinoma	Sacituzumab govitecan