Regulatory approval

Published by the European Medicines Agency. Approved

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.

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

Contributions

Date	Contributor	Description
2024-10-20	Van Allen lab	Adding EMA approvals for use to database
2018-08-31	European Medicines Agency	Indication received approval from the European Commission.