Regulatory approval

Published by the Health Canada.

Health Canada approved neratinib in combination with capecitabine for the treatment of patients with metastatic HER2-overexpressed/amplified breast cancer, who have received two or more prior anti-HER2-based regimens in the metastatic setting.

This is written in the approval document as:

NERLYNX (neratinib) is indicated in combination with capecitabine for the treatment of patients with metastatic HER2-overexpressed/amplified breast cancer, who have received two or more prior anti-HER2-based regimens in the metastatic setting.

Citation

Knight Therapeutics Inc. Nerlynx (neratinib) [product monograph]. Health Canada website. https://pdf.hres.ca/dpd_pm/00062158.PDF. Revised July 2021. Accessed June 2025.

Therapeutic response

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

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