Therapeutic Response Statement (Sensitivity)

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

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 statement is based on a regulatory approval from the European Medicines Agency:

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.

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.