Tykerb (lapatinib) [product monograph]. HC.

Regulatory approval published by the Health Canada.

Citation

Novartis Pharmaceuticals Canada Inc. Tykerb (lapatinib) [product monograph]. Health Canada website. https://pdf.hres.ca/dpd_pm/00064944.PDF. Revised March 2022. Accessed June 2025.

Regulatory approvals

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

Indication	Statements
TYKERB (lapatinib tablets) is indicated for in combination with capecitabine, for the treatment of patients with metastatic breast cancer whose tumours overexpress ErbB2 (HER2). Patients should have progressed on taxanes and anthracycline before starting this therapy. In addition, patients should have progressed on prior trastuzumab therapy in the metastatic setting.	1

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	HER2-positive	Invasive Breast Carcinoma	Capecitabine, Lapatinib