Therapeutic Response Statement (Sensitivity)

This therapeutic response statement Supports the relationship that ER negative, HER2-negative, PD-L1 (CPS) >= 10, and PR negative status confers therapeutic sensitivity to Pembrolizumab, Sacituzumab govitecan in patients with Invasive Breast Carcinoma.

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 statement is based on a regulatory approval from the Food and Drug Administration:

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. 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 6, 2026.

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.