Regulatory approval

Published by the European Medicines Agency.

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 (see section 5.1).

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 August 2023. Accessed March 25, 2024.

Therapeutic response

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

Type	Biomarker(s)	Cancer type	Therapy(ies)
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