Therapeutic Response Statement (Sensitivity)

This therapeutic response statement Supports the relationship that ER negative, HER2-negative, and PR negative status confers therapeutic sensitivity to Sacituzumab govitecan in patients with Invasive Breast Carcinoma.

The European Medicines Agency (EMA) has authorized sacituzumab govitecan as a monotherapy for the treatment of adult patients with locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic disease and who are not candidates for PD-1 or PD-L1 inhibitor therapy.

This statement is based on a regulatory approval from the European Medicines Agency:

Trodelvy as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic disease and who are not candidates for PD-1 or PD-L1 inhibitor therapy.

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.

Contributions

Date	Contributor	Description
2026-08-02	Van Allen lab	Initial curation of into moalmanac-db
2026-07-16	European Medicines Agency	Indication received approval from the European Commission.