Extended indication Nerlynx is indicated for the extended adjuvant treatment of adult patients with early-stage hormone
Therapeutic value No judgement
Total cost 29,080,000.00
Registration phase Registered


Active substance Neratinib
Domain Oncology and Hematology
Reason of inclusion New medicine (specialité)
Main indication Breast cancer
Extended 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.
Proprietary name Nerlynx
Manufacturer Puma
Mechanism of action Tyrosine kinase inhibitor
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Intermural (MSZ)
Additional comments Tyrosine kinase inhibitor. Adjuvante setting, na trastuzumab. 2-jaars ziekte vrije overleving (DFS; disease-free survival) gepubliceerd, maar commissie BOM eist 5 jaar follow-up voor uitspraak.


Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date September 2016
Expected Registration August 2018
Orphan drug No
Registration phase Registered
Additional comments Negatieve CHMP opinie februari 2018. Fabrikant heeft een herbeoordeling aangevraagd. Positieve CHMP-opinie in juli 2018. Geregistreerd in augustus 2018.

Therapeutic value

Therapeutic value No judgement
Substantiation Wordt zowel adjuvant als in gemetastaseerde setting onderzocht bij HER2 neu + tumoren. Studieresultaten vooorlopig nog niet verwacht; nog geen schatting mogelijk.
Duration of treatment Average 12 month / months
Frequency of administration 1 times a day
Dosage per administration 240 mg

Expected patient volume per year

Patient volume

624 - 830

Market share is generally not included unless otherwise stated.

References NKR
Additional comments NKR: stadium 2, HER2+ betreft 830 patiënten, hiervan wordt 75% behandeld met een targeted therapy (=trastuzumab) = 624 patiënten.

Expected cost per patient per year

Cost 30,000.00 - 50,000.00
Additional comments Lapatinib kost nu maximaal €40.000,00 p.p.p.j..

Potential total cost per year

Total cost


This amount gives an indication of the total cost. It is the result of the average expected patient volume times the average cost per patient. both per year.

Off label use

There is currently nothing known about off label use.

Indication extension

Indication extension Yes
Indication extensions Breast cancer, advanced HER-2-positive - 3rd-line in combination with capecitabine (PhIII).

Other information

There is currently no futher information available.