Regulatory approval

Published by the European Medicines Agency. Approved

The European Medicines Agency (EMA) has authorized sacituzumab govitecan 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.

This is written in the approval document as:

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.

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 July 2026. Accessed August 2, 2026.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

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

Contributions

Date	Contributor	Description
2024-10-20	Van Allen lab	Adding EMA approvals for use to database
2023-07-26	European Medicines Agency	Indication received approval from the European Commission.