Extended indication Gevorderd niet-kleincellig longcarcinoom, als toevoeging aan pembrolizumab en chemotherapie.
Therapeutic value No judgement
Registration phase Clinical trials

Product

Active substance Canakinumab
Domain Oncology and Hematology
Reason of inclusion Indication extension
Main indication Lung cancer
Extended indication Gevorderd niet-kleincellig longcarcinoom, als toevoeging aan pembrolizumab en chemotherapie.
Manufacturer Novartis
Mechanism of action Interleukin inhibitor
Route of administration Subcutaneous
Therapeutical formulation Injection liquid
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date January 2022
Expected Registration January 2023
Orphan drug No
Registration phase Clinical trials
Additional comments Voor niet-oncologische indicaties is canakinumab reeds op de markt onder de merknaam Ilaris. De fabrikant verwacht registratie in januari 2023.

Therapeutic value

Current treatment options Pembrolizumab, nivolumab, atezolizumab, durvalumab.
Therapeutic value No judgement
Frequency of administration 1 times every 3 weeks
References J Thorac Dis. 2018 Sep;10(Suppl 26):S3084-S3087. doi: 10.21037/jtd.2018.07.50 NCT03631199.
Additional comments Op dit moment zijn er nog geen resultaten bekend. De gerandomiseerde fase 3 studie wordt gecompleteerd in medio 2022.

Expected patient volume per year

References Declaratie gegevens
Additional comments In 2019 is er 1169 keer pembrolizumab in combinatie met pemetrexed en platinumbevattende chemotherapie voor de eerstelijnsbehandeling van gemetastaseerd niet-plaveiselcel niet-kleincellig longcarcinoom (NSCLC) bij volwassenen met tumoren zonder EGFR- of ALK-positieve mutaties gedeclareerd.

Expected cost per patient per year

References FK
Additional comments Prijs per injectieflacon €11.990.

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 Yes
Indication extensions Behcet's syndrome; Pneumonia.
References Adisinsight.
Additional comments Lopende fase 3 studies.

Other information

There is currently no futher information available.