Pegargiminase Medicine 03 June 2025 Extended indication Pegargiminase in combination with pemetrexed, cisplatin, and carboplatin for first line treatment of unresectable Pleural mesothelioma malignant in adults and elderly. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Pegargiminase Domain Oncology Reason of inclusion New medicine (specialité) Main indication Lung cancer Extended indication Pegargiminase in combination with pemetrexed, cisplatin, and carboplatin for first line treatment of unresectable Pleural mesothelioma malignant in adults and elderly. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Polaris Portfolio holder Mechanism of action Other, see general comments Route of administration Intramuscular Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Vervanging van arginine-deiminase. Registration Registration route Centralised (EMA) Type of trajectory Particularity ATMP No Submission date June 2026 Expected Registration July 2027 Orphan drug Yes Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Tijdslijn op basis van IHSI-inschatting. Therapeutic value Current treatment options Nivolumab en ipilimumab. Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Er zijn nog geen resultaten bekend. Duration of treatment Frequency of administration Dosage per administration References NCT02709512 Additional remarks Expected patient volume per year Patient volume < 225 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Pakketadvies ipilimumab bij mesothelioom Additional remarks Totale aantal patiënten dat jaarlijks voor ipilimumab plus nivolumab in aanmerking komt. Incidente patiënten: 225 patiënten in het derde jaar na de introductie (= 56 patiënten met niet-epitheloïde tumor histologie + 169 patiënten met epitheloïde tumor histologie). Expected cost per patient per year Cost References Pakketadvies ipilimumab bij mesothelioom (2021) Additional remarks Er is nog niet bekend over de kosten. Voor de huidige behandeling van nivolumab in combinatie met ipilimumab bedragen de kosten € 95.446,26 per patiënt, waarvan € 35.299 voor rekening komt van ipilimumab. Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks