Durvalumab Medicine 03 June 2025 Extended indication Durvalumab in combination with enfortumab vedotin for neoadjuvant and durvalumab monotherapy for adjuvant treatment of muscle-invasive urothelial carcinoma bladder in adults and elderly who are cisplatin-ineligible or refused cisplatin and are undergoing radical cystectomy (VOLGA). Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Durvalumab Domain Oncology Reason of inclusion Indication extension IND Main indication Bladder cancer Extended indication Durvalumab in combination with enfortumab vedotin for neoadjuvant and durvalumab monotherapy for adjuvant treatment of muscle-invasive urothelial carcinoma bladder in adults and elderly who are cisplatin-ineligible or refused cisplatin and are undergoing radical cystectomy (VOLGA). Current proprietary name Already available biosimilars / generics Proprietary name Imfinzi Manufacturer AstraZeneca Portfolio holder AstraZeneca Mechanism of action PD-1 / PD-L1 inhibitor Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date 2026 Expected Registration 2027 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Broadly excluded Additional remarks Fabrikant verwacht registratie in het eerste kwartaal van 2027. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration References Additional remarks Er zijn nog geen studieresultaten bekend. NCT04960709 (VOLGA). Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR; Leliveld-Kors, A. (2014). Urothelial Cell Carcinoma: Patterns of care and contemporary urography. [S.n.]. (record atezolizumab) Additional remarks Jaarlijks zijn er 1.700 tot 1.800 patiënten met de diagnose spierinvasief blaaskanker. Hiervan zijn er 1.100 tot 1.200 met de diagnose T2-T4a, N0, M0 (spierinvasief, niet gevorderd). Hiervan zal ongeveer een derde cystectomie ondergaan (400). Van deze patiënten zal een deel mogelijk in aanmerking komen voor behandeling met durvalumab. Expected cost per patient per year Cost € 45,000.00 - 90,000.00 This amount gives an indication of the total cost. It is the result of the average expected patient volume times the average cost per patient. both per year. References medicijnkosten.nl Additional remarks De prijs per 2,4 mL flacon (50mg/ml) durvalumab (Imfinzi) is €444. De jaarlijkse kosten zijn afhankelijk van de dosering en behandelduur. Inschatting: in lijn met andere indicaties. Deze kosten betreffen alleen durvalumab. 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