Neratinib

Active substance
Neratinib
Domain
Oncology and Hematology
Reason of inclusion in Horizonscan Geneesmiddelen
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.

1. Product

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.

2. Registration

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.

3. 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

4. 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.

5. Expected cost per patient per year

Cost
30,000 - 50,000
Additional comments
Lapatinib kost nu maximaal €40.000,00 per patiënt per jaar.

6. Potential total cost per year

Total cost

29,080,000

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.

7. Off label use

There is currently nothing known about off label use.

8. Indication extension

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

9. Other information

There is currently no futher information available.