Regulatory approval

Published by the European Medicines Agency. Approved

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.

This is written in the approval document.

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.