Afatinib

Active substance
Afatinib
Domain
Oncology and Hematology
Reason of inclusion in Horizonscan Geneesmiddelen
Indication extension
Main indication
Head and neck cancer
Extended indication
Head and neck (or upper airways tract) cancers, locally advanced (recurrent/metastatic) squamous cell, 2nd line after platinum therapy

1. Product

Proprietary name
Giotrif
Manufacturer
Boehringer Ingelheim
Mechanism of action
Tyrosine kinase inhibitor
Route of administration
Oral
Therapeutical formulation
Tablet
Budgetting framework
Intermural (MSZ)
Additional comments
antineoplastische stoffen, proteïnekinaseremmers

2. Registration

Registration route
Centralised (EMA)
Submission date
2021
Expected Registration
2022
Orphan drug
No
Registration phase
Clinical trials
Additional comments
Al op de markt voor EGFR+ NSCLC, 1L en plaveiselcel NSCLC, 2L. Fabrikant geeft aan dat het niet bekend is wanneer dit geneesmiddel ingediend zal worden. Verwachte indieningsdatum en verwachte registratiedatum op basis van estimated primary completion date fase 3 studie in november 2021.

3. Therapeutic value

Current treatment options
Methotrexate. Andere immunotherapiën en PD1/PDL1-remmers.
Therapeutic value
No judgement
Duration of treatment
Not found
Frequency of administration
1 times a day
Dosage per administration
40 mg
References
NCT01427478

4. Expected patient volume per year

References
NKR 2015
Additional comments
Hoofd-hals tumoren, stadium 3 en 4, respectivelijk 427 en 1.189 (in totaal 1.616). Gezien het gaat om een 2L behandeling en gezien de huidige behandelopties / concurrentie zal het realistisch patiëntvolume lager liggen.

5. Expected cost per patient per year

Cost
25,000
References
G-standaard; Fabrikant
Additional comments
De prijs van het middel dat nu al op de markt is voor NSCLC is €2113,57 per maand.

6. Potential total cost per year

There is currently nothing known about the possible total cost.

7. Off label use

There is currently nothing known about off label use.

8. Indication extension

Indication extension
No
References
clinicaltrials.gov

9. Other information

There is currently no futher information available.