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

June 2021

Expected Registration

June 2022

Orphan drug

No

Registration phase

Clinical trials

Additional comments
Voor niet-oncologische indicaties is canakinumab reeds op de markt onder de merknaam Ilaris.

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

There is currently nothing known about the expected patient volume.

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.