Regulatory approval

Published by the Food and Drug Administration. Approved

The U.S. Food and Drug Administration granted approval to sacituzumab govitecan, in combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph, for the first-line treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 [Combined Positive Score (CPS >= 10)] as determined by an FDA-authorized test.

This is written in the approval document as:

TRODELVY is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated, in combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph, for the first-line treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 [Combined Positive Score (CPS >= 10)] as determined by an FDA-authorized test.

Citation

Gilead Sciences, Inc. Trodelvy (sacituzumab govitecan) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761115s064lbl.pdf. Revised June 2026. Accessed October 13, 2026.

Therapeutic response

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

Organizations	Biomarkers	Cancer types	Therapies
FDA (2)	ER negative, HER2-negative, PD-L1 (CPS) >= 10, PR negative	Invasive Breast Carcinoma	Pembrolizumab, Sacituzumab govitecan

Contributions

Date	Contributor	Description
2026-10-13	Van Allen lab	Initial curation of this indication into moalmanac-db.
2026-06-24	Food and Drug Administration	Indication received traditional approval.