Regulatory approval

Published by the Health Canada.

Health Canada approved sacituzumab govitecan for the treatment of adult patients with unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.

This is written in the approval document as:

TRODELVY (sacituzumab govitecan) is indicated for the treatment of adult patients with unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.

Citation

Gilead Sciences Canada, Inc. Trodelvy (sacituzumab govitecan) [product monograph]. Health Canada website. https://pdf.hres.ca/dpd_pm/00080546.PDF. Published May 2025. Accessed June 2025.

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