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

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

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.

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

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.

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.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

Indication extension No
References clinicaltrials.gov

Other information

There is currently no futher information available.