Mitomycine (UGN-103) Medicine 04 June 2026 Extended indication Mitomycin (UGN-103) monotherapy for first line treatment of intermediate-risk low-grade Non-muscle invasive bladder cancer (NMIBC) in adults and elderly. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Mitomycine (UGN-103) Domain Oncology Reason of inclusion New medicine (specialité) Main indication Bladder cancer Extended indication Mitomycin (UGN-103) monotherapy for first line treatment of intermediate-risk low-grade Non-muscle invasive bladder cancer (NMIBC) in adults and elderly. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Urogen Portfolio holder Urogen Mechanism of action Route of administration Intravesical Therapeutical formulation Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Particularity ATMP No Submission date June 2026 Expected Registration July 2027 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Conventioneel mitomycine Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Voorlopige data van de fase 3 UTOPIA studie lijkt een hoge complete response (CR) percentage te laten zien voor de intravesicale behandeling van NMIBC met UGN-103. Het gerapporteerde CR percentage was na 3 maanden gelijk aan 77.% (95% CI, 68.3%-85.5%). Daarnaast heeft de US Food and Drug Administration (FDA) ermee ingestemd dat deze bevindingen kunnen dienen ter ondersteuning van een New Drug Application (NDA) voor UGN-103. Verdere data wordt verwacht op ASCO2026. Duration of treatment Frequency of administration Dosage per administration References NCT06331299 (UTOPIA trial); Expertopinie Additional remarks Expected patient volume per year Patient volume < 3,723 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR 2023(1) Additional remarks In 2023 waren er 3.723 patiënten met niet-invasieve blaaskanker (NMIBC) (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