Nerlynx (neratinib) [product monograph]. HC.

Regulatory approval published by the Health Canada.

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.

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Regulatory approvals

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

Indication Statements
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. 3
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. 1

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

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