Nerlynx (neratinib) [product information]. EMA.

Regulatory approval published by the European Medicines Agency.

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.

Regulatory approvals

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

Indication	Statements
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.	6

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 (+)	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