Nerlynx

neratinib

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An overview of Nerlynx and why it is authorised in the EU

Nerlynx is a breast cancer medicine used to reduce the risk of the disease coming back in patients with early breast cancer who have had surgery. It is given following treatment with trastuzumab (another medicine used for the same purpose).

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).

How is Nerlynx used?

Nerlynx treatment should be started and supervised by a doctor experienced in giving cancer medicines and can only be obtained with a prescription.

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.

For more information about using Nerlynx, see the package leaflet or contact your doctor or pharmacist.

How does Nerlynx work?

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.

What benefits of Nerlynx have been shown in studies?

Nerlynx has been shown to be more effective than placebo (a dummy treatment) at preventing the cancer from coming back in one main study involving 2,840 women with HER2-positive early breast cancer who had already received trastuzumab.

Around 94% of the women given a year’s treatment with Nerlynx lived for 1 further year after stopping Nerlynx without their cancer coming back versus 92% of those given placebo. When only women with hormone-receptor positive cancer were considered, about 95% of those given Nerlynx lived another year without the cancer coming back versus 91% of those given placebo.

What are the risks associated with Nerlynx?

The most common side effect with Nerlynx is diarrhoea, which affects nearly all patients. Other common side effects (which may affect more than 1 in 10 people) are nausea (feeling sick), vomiting, tiredness, belly pain, rash, decreased appetite, stomatitis (sore, inflamed mouth), and muscle spasms. The most common serious side effects are diarrhoea and vomiting. For the full list of side effects of Nerlynx, see the package leaflet.

Nerlynx must not be used in patients with severely reduced liver function. It must also not be used with certain medicines that affect the way Nerlynx is broken down in the body. For the full list of restrictions, see the package leaflet.

Why is Nerlynx authorised in the EU?

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.

What measures are being taken to ensure the safe and effective use of Nerlynx?

The company that markets Nerlynx will provide a guide for healthcare professionals who prescribe or dispense the medicine, and educational material for patients and carers. These materials will explain the effects of Nerlynx on the gut, such as diarrhoea, and how to manage them, and will give advice on the need for patients to tell their healthcare professionals of side effects.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Nerlynx have also been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Nerlynx are continuously monitored. Side effects reported with Nerlynx are carefully evaluated and any necessary action taken to protect patients.

Other information about Nerlynx

Nerlynx received a marketing authorisation valid throughout the EU on 31 August 2018.

Name Language First published Last updated
Nerlynx : EPAR - Medicine overview BG = bălgarski 2018-09-12  
Nerlynx : EPAR - Medicine overview ES = español 2018-09-12  
Nerlynx : EPAR - Medicine overview CS = čeština 2018-09-12  
Nerlynx : EPAR - Medicine overview DA = dansk 2018-09-12  
Nerlynx : EPAR - Medicine overview DE = Deutsch 2018-09-12  
Nerlynx : EPAR - Medicine overview ET = eesti keel 2018-09-12  
Nerlynx : EPAR - Medicine overview EL = elliniká 2018-09-12  
Nerlynx : EPAR - Medicine overview EN = English 2018-09-12  
Nerlynx : EPAR - Medicine overview FR = français 2018-09-12  
Nerlynx : EPAR - Medicine overview IT = italiano 2018-09-12  
Nerlynx : EPAR - Medicine overview LV = latviešu valoda 2018-09-12  
Nerlynx : EPAR - Medicine overview LT = lietuvių kalba 2018-09-12  
Nerlynx : EPAR - Medicine overview HU = magyar 2018-09-12  
Nerlynx : EPAR - Medicine overview MT = Malti 2018-09-12  
Nerlynx : EPAR - Medicine overview NL = Nederlands 2018-09-12  
Nerlynx : EPAR - Medicine overview PL = polski 2018-09-12  
Nerlynx : EPAR - Medicine overview PT = português 2018-09-12  
Nerlynx : EPAR - Medicine overview RO = română 2018-09-12  
Nerlynx : EPAR - Medicine overview SK = slovenčina 2018-09-12  
Nerlynx : EPAR - Medicine overview SL = slovenščina 2018-09-12  
Nerlynx : EPAR - Medicine overview FI = suomi 2018-09-12  
Nerlynx : EPAR - Medicine overview SV = svenska 2018-09-12  
Nerlynx : EPAR - Medicine overview HR = Hrvatski 2018-09-12  
Name Language First published Last updated
Nerlynx : EPAR - Risk-management-plan summary (English only) 2018-09-12  

This EPAR was last updated on 12/09/2018 .

Authorisation details

Product details

Product details for Nerlynx
NameNerlynx
Agency product numberEMEA/H/C/004030
Active substance

neratinib

International non-proprietary name (INN) or common name

neratinib

Therapeutic area Breast Neoplasms
Anatomical therapeutic chemical (ATC) code L01X
Additional monitoring

This medicine is under additional monitoring. This means that it is being monitored even more intensively than other medicines. For more information, see medicines under additional monitoring.

Publication details

Publication details for Nerlynx
Marketing-authorisation holder

Puma Biotechnology Limited

Revision0
Date of issue of marketing authorisation valid throughout the European Union31/08/2018

Contact address:

Puma Biotechnology Limited
11th Floor
Whitefriars Lewins Mead
Bristol BS1 2NT
United Kingdom

Product information

Product information

31/08/2018  Nerlynx -EMEA/H/C/004030 --

Name Language First published Last updated
Nerlynx : EPAR - Product Information EN = English 2018-09-12  
Nerlynx : EPAR - Product Information EN = English 2018-09-12  
Nerlynx : EPAR - Product Information EN = English 2018-09-12  
Nerlynx : EPAR - Product Information EN = English 2018-09-12  
Nerlynx : EPAR - Product Information EN = English 2018-09-12  
Nerlynx : EPAR - Product Information EN = English 2018-09-12  
Nerlynx : EPAR - Product Information EN = English 2018-09-12  
Nerlynx : EPAR - Product Information EN = English 2018-09-12  
Nerlynx : EPAR - Product Information EN = English 2018-09-12  
Nerlynx : EPAR - Product Information EN = English 2018-09-12  
Nerlynx : EPAR - Product Information EN = English 2018-09-12  
Nerlynx : EPAR - Product Information EN = English 2018-09-12  
Nerlynx : EPAR - Product Information EN = English 2018-09-12  
Nerlynx : EPAR - Product Information EN = English 2018-09-12  
Nerlynx : EPAR - Product Information EN = English 2018-09-12  
Nerlynx : EPAR - Product Information EN = English 2018-09-12  
Nerlynx : EPAR - Product Information EN = English 2018-09-12  
Nerlynx : EPAR - Product Information EN = English 2018-09-12  
Nerlynx : EPAR - Product Information EN = English 2018-09-12  
Nerlynx : EPAR - Product Information EN = English 2018-09-12  
Nerlynx : EPAR - Product Information EN = English 2018-09-12  
Nerlynx : EPAR - Product Information EN = English 2018-09-12  
Nerlynx : EPAR - Product Information EN = English 2018-09-12  
Nerlynx : EPAR - Product Information EN = English 2018-09-12  
Nerlynx : EPAR - Product Information EN = English 2018-09-12  

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Nerlynx : EPAR - All Authorised presentations EN = English 2018-09-12  
Nerlynx : EPAR - All Authorised presentations EN = English 2018-09-12  
Nerlynx : EPAR - All Authorised presentations EN = English 2018-09-12  
Nerlynx : EPAR - All Authorised presentations EN = English 2018-09-12  
Nerlynx : EPAR - All Authorised presentations EN = English 2018-09-12  
Nerlynx : EPAR - All Authorised presentations EN = English 2018-09-12  
Nerlynx : EPAR - All Authorised presentations EN = English 2018-09-12  
Nerlynx : EPAR - All Authorised presentations EN = English 2018-09-12  
Nerlynx : EPAR - All Authorised presentations EN = English 2018-09-12  
Nerlynx : EPAR - All Authorised presentations EN = English 2018-09-12  
Nerlynx : EPAR - All Authorised presentations EN = English 2018-09-12  
Nerlynx : EPAR - All Authorised presentations EN = English 2018-09-12  
Nerlynx : EPAR - All Authorised presentations EN = English 2018-09-12  
Nerlynx : EPAR - All Authorised presentations EN = English 2018-09-12  
Nerlynx : EPAR - All Authorised presentations EN = English 2018-09-12  
Nerlynx : EPAR - All Authorised presentations EN = English 2018-09-12  
Nerlynx : EPAR - All Authorised presentations EN = English 2018-09-12  
Nerlynx : EPAR - All Authorised presentations EN = English 2018-09-12  
Nerlynx : EPAR - All Authorised presentations EN = English 2018-09-12  
Nerlynx : EPAR - All Authorised presentations EN = English 2018-09-12  
Nerlynx : EPAR - All Authorised presentations EN = English 2018-09-12  
Nerlynx : EPAR - All Authorised presentations EN = English 2018-09-12  
Nerlynx : EPAR - All Authorised presentations EN = English 2018-09-12  
Nerlynx : EPAR - All Authorised presentations EN = English 2018-09-12  
Nerlynx : EPAR - All Authorised presentations EN = English 2018-09-12  

Pharmacotherapeutic group

Antineoplastic Agents

Therapeutic indication

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.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Name Language First published Last updated
Nerlynx : EPAR - Public assessment report EN = English 2018-09-12  
CHMP summary of positive opinion for Nerlynx EN = English 2018-06-29