Regulatory approval

Published by the Health Canada. Approved

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.

This is written in the approval document.

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.

Therapeutic response

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

Organizations	Biomarkers	Cancer types	Therapies
HC (1)	HER2-positive	Invasive Breast Carcinoma	Capecitabine, Lapatinib

Contributions

Date	Contributor	Description
2024-10-30	Van Allen lab	Initial access of FDA approvals