Trodelvy (sacituzumab govitecan) [product monograph]. HC.

Regulatory approval published by the Health Canada.

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.

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Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication Statements
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. 2

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

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