Ozekibart Medicine 03 December 2024 Extended indication Ozekibart monotherapie voor de behandeling van gemetastaseerd of niet-reseceerbaar conventioneel chondrosarcoom bij volwassenen en ouderen. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Ozekibart Domain Oncology Reason of inclusion New medicine (specialité) Main indication Oncology other Extended indication Ozekibart monotherapie voor de behandeling van gemetastaseerd of niet-reseceerbaar conventioneel chondrosarcoom bij volwassenen en ouderen. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Inhibrx Biosciences Portfolio holder Mechanism of action Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Tetravalent recombinant humanized IgG1 agonist antibody targeting the human TRAIL death receptor 5 (DR5). Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date June 2026 Expected Registration June 2027 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Indieningsdatum en verwachte registratie op basis van IHSI-inschatting. Therapeutic value Current treatment options Operatie. Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Op dit moment loopt er nog een fase 2 studie. Duration of treatment Frequency of administration Dosage per administration References NCT04950075 (ChonDRAgon) Additional remarks Expected patient volume per year Patient volume 40 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Kanker.nl (1) Additional remarks Elk jaar krijgen ongeveer 40 mensen de diagnose chondrosarcoom (1). Expected cost per patient per year Cost References Additional remarks 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