Canakinumab Medicine 10 June 2020 Extended indication Gevorderd niet-kleincellig longcarcinoom, als toevoeging aan pembrolizumab en chemotherapie. Therapeutic value No judgement Total cost Registration phase Clinical trials Product Active substance Canakinumab Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Lung cancer Extended indication Gevorderd niet-kleincellig longcarcinoom, als toevoeging aan pembrolizumab en chemotherapie. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Novartis Portfolio holder Mechanism of action Interleukin inhibitor Route of administration Subcutaneous Therapeutical formulation Injection liquid Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date January 2022 Expected Registration January 2023 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks 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 This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 1 times every 3 weeks Dosage per administration References J Thorac Dis. 2018 Sep;10(Suppl 26):S3084-S3087. doi: 10.21037/jtd.2018.07.50 NCT03631199. Additional remarks Op dit moment zijn er nog geen resultaten bekend. De gerandomiseerde fase 3 studie wordt gecompleteerd in medio 2022. Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Declaratie gegevens Additional remarks 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 Cost References FK Additional remarks Prijs per injectieflacon €11.990. Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions Behcet's syndrome; Pneumonia. References Adisinsight. Additional remarks Lopende fase 3 studies. Other information Additional remarks