Abnobaviscum 900 Medicine 04 June 2024 Extended indication Abnobaviscum 900 monotherapy for second line treatment of completely resected superficial intermediate-risk Bladder carcinoma in adults and elderly. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Abnobaviscum 900 Domain Oncology Reason of inclusion New medicine (specialité) Main indication Bladder cancer Extended indication Abnobaviscum 900 monotherapy for second line treatment of completely resected superficial intermediate-risk Bladder carcinoma in adults and elderly. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Portfolio holder Mechanism of action Unknown Route of administration Intravesical Therapeutical formulation Infusion fluid Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Abnobaviscum 900 enforces natural killer cell-mediated tumor cell lysis, reduces the migratory and invasive potential of tumor cells, and stimulates immune system cells both in vitro and in vivo. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP No Submission date March 2025 Expected Registration April 2026 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks 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 1 times a month Dosage per administration References NCT02106572 Additional remarks Intravesical instillation of abnobaVISCUM 900 13 times during treatment period Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks 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 Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks