Regulatory approval

Published by the European Medicines Agency.

The European Medicines Agency (EMA) has authorized neratinib for the extended adjuvant treatment of adult patients 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 as:

Nerlynx is indicated for the extended adjuvant treatment of adult patients with early-stage hormone receptor positive HER2-overexpressed/amplified breast cancer and who completed adjuvant trastuzumab-based therapy less than one year ago.

Citation

Pierre Fabre Medicament. Nerlynx (neratinib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/nerlynx-epar-product-information_en.pdf. Revised June 2023. Accessed March 20, 2024.

Therapeutic response

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

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 (+)	ER positive, ERBB2 amplification, PR positive	Invasive Breast Carcinoma	Neratinib
Sensitivity (+)	ER positive, ERBB2 amplification	Invasive Breast Carcinoma	Neratinib
Sensitivity (+)	ERBB2 amplification, PR positive	Invasive Breast Carcinoma	Neratinib