Nerlynx is indicated for the extended adjuvant treatment of adult patients with early stage hormone receptor positive HER2-overexpressed/amplified breast cancer and who are less than one year from the completion of prior adjuvant trastuzumab based therapy.
It is intended for use only in breast cancers that produce high levels of a protein called HER2, which helps cells to divide and grow (HER2-positive breast cancer), and that also have receptors (targets) for the female sex hormones (hormone-receptor positive breast cancer).
The medicine is available as tablets (40 mg). The recommended dose is 6 tablets (240 mg) once a day with food, preferably in the morning. Treatment should be started within a year of finishing treatment with trastuzumab, and is given for 1 year. The doctor may reduce the dose or stop treatment if a patient has severe side effects, including diarrhoea. The doctor may also modify the dose if Nerlynx is given with certain other medicines. Patients are given treatment to prevent diarrhoea when starting Nerlynx.
The active substance in Nerlynx, neratinib, is a type of cancer medicine called a tyrosine kinase inhibitor. It attaches to the HER2 protein on the cancer cells, and so blocks its action. Because HER2 helps cancer cells to grow and divide, blocking it helps to stop these cells growing and prevents the cancer from coming back.
The European Medicines Agency considered that Nerlynx had been shown to be of benefit in women with HER2-positive early breast cancer, and that this benefit seemed to be mainly in women with hormone-receptor positive disease.
Although the side effects, particularly diarrhoea, can be severe and lead to treatment being stopped, there would be patients with HER2-positive, hormone-receptor positive early breast cancer for whom treatment with Nerlynx after surgery and trastuzumab would be a reasonable option. The Agency therefore decided that Nerlynx’s benefits are greater than its risks in this group and it can be authorised for use in the EU.
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