Therapeutic Response Statement (Sensitivity)

This therapeutic response statement supports the relationship that ER positive, HER2-positive, PR positive status confers therapeutic sensitivity to Neratinib in patients with Invasive Breast Carcinoma.

This statement is based on a regulatory approval from the Health Canada:

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.

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.