Zanidatamab Medicine 03 December 2024 Extended indication Second line treatment of locally advanced unresectable HER2-positive biliary cancer metastatic in adults and elderly, monotherapy Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Zanidatamab Domain Oncology Reason of inclusion New medicine (specialité) Main indication Oncology other Extended indication Second line treatment of locally advanced unresectable HER2-positive biliary cancer metastatic in adults and elderly, monotherapy Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Jazz Portfolio holder Mechanism of action Other, see general comments Route of administration Intravenous Therapeutical formulation Concentrate for solution Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Zanidatamab is een bispecifiek antilichaam met affiniteit voor twee epitopen van HER2. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date June 2024 Expected Registration July 2025 Orphan drug Yes Registration phase Registration application pending 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 De resultaten van de fase III HERIZON-GEA-01 studie zijn nog niet bekend. Duration of treatment Frequency of administration 1 times every 2 weeks Dosage per administration 20 mg/kg References NCT04466891 (HERIZON-BTC-01); NCT05152147 (HERIZON-GEA-01). Additional remarks Expected patient volume per year Patient volume 11 - 44 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR 2024 (1). Ostwal et al. JCO. 2023 (2). Additional remarks In 2022 werden er 273 mensen met galwegkanker (proximaal, distaal en overig) gediagnosticeerd, stadium III en IV (1). HER2 overexpressie wordt gezien bij 4 tot 16% van alle galwegkankers (2). 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