Zanidatamab Medicine 03 June 2025 Extended indication Zanidatamab in combination with chemotherapy for first line treatment of unresectable locally advanced, recurrent or metastatic HER2-positive gastric, gastro-oesophageal junction and oesophageal adenocarcinoma in adults and elderly. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Zanidatamab Domain Oncology Reason of inclusion Indication extension IND Main indication Oncology other Extended indication Zanidatamab in combination with chemotherapy for first line treatment of unresectable locally advanced, recurrent or metastatic HER2-positive gastric, gastro-oesophageal junction and oesophageal adenocarcinoma in adults and elderly. Current proprietary name Already available biosimilars / generics Proprietary name Ziihera 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 August 2025 Expected Registration September 2026 Orphan drug Yes 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 De resultaten van de fase 3 HERIZON-GEA-01 studie zijn nog niet bekend. Duration of treatment Frequency of administration Dosage per administration References NCT05152147 (HERIZON-GEA-01) Additional remarks 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