Regulatory approval

Published by the Health Service Executive. Approved

Extended adjuvant treatment of adults with early-stage hormone receptor-positive, HER2-overexpressed/amplified breast cancer and who completed adjuvant trastuzumab-based therapy less than one year ago.

This is written in the approval document.

Reimbursement

CDS

Citation

Neratinib Therapy, 2024, version number 2, NCCP National SACT Regimen, NCCP, viewed 26/03/2026, https://healthservice.hse.ie/documents/6596/720_v2_Neratinib.pdf

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Therapeutic response

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

Organizations Biomarkers Cancer types Therapies
HSE (1) ER positive, HER2-positive, PR positive Invasive Breast Carcinoma Neratinib
HSE (1) ER positive, HER2-positive Invasive Breast Carcinoma Neratinib
HSE (1) HER2-positive, PR positive Invasive Breast Carcinoma Neratinib
HSE (1) ER positive, ERBB2 amplification, PR positive Invasive Breast Carcinoma Neratinib
HSE (1) ER positive, ERBB2 amplification Invasive Breast Carcinoma Neratinib
HSE (1) ERBB2 amplification, PR positive Invasive Breast Carcinoma Neratinib