Regulatory approval

Published by the Health Canada. Approved

NERLYNX (neratinib) is indicated for the extended adjuvant treatment of women with early-stage hormone receptor positive and HER2-overexpressed/amplified breast cancer, within one year after completion of trastuzumab-based adjuvant therapy.

This is written in the approval document.

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.

Organizations	Biomarkers	Cancer types	Therapies
HC (1)	ER positive, HER2-positive, PR positive	Invasive Breast Carcinoma	Neratinib
HC (1)	ER positive, HER2-positive	Invasive Breast Carcinoma	Neratinib
HC (1)	HER2-positive, PR positive	Invasive Breast Carcinoma	Neratinib

Contributions

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