2 Information about neratinib

Marketing authorisation indication

2.1

Neratinib (Nerlynx, Pierre Fabre) is indicated for 'the extended adjuvant treatment of adults with early stage hormone receptor-positive, HER2-overexpressed/amplified breast cancer and who are less than 1 year from the completion of prior adjuvant trastuzumab-based therapy'.

Dosage in the marketing authorisation

2.2

Neratinib is administered orally. The recommended dose is 240 mg neratinib, administered as 6×40‑mg tablets taken once daily and continually for 1 year.

Price

2.3

The list price is £4,500 per box of 180 tablets (30 days treatment; excluding VAT; company's submission).

2.4

The company has a commercial arrangement. This makes neratinib available to the NHS with a discount. The size of the discount is commercial in confidence. It is the company's responsibility to let relevant NHS organisations know details of the discount.