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Zanidatamab

Extended indication Second line treatment of locally advanced unresectable HER2-positive biliary cancer metastatic in ad
Therapeutic value No estimate possible yet
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
Manufacturer Jazz
Mechanism of action Other, see general comments
Route of administration Intravenous
Therapeutical formulation Concentrate for solution
Budgetting framework Intermural (MSZ)
Additional remarks Zanidatamab is een bispecifiek antilichaam met affiniteit voor twee epitopen van HER2.

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date June 2024
Expected Registration July 2025
Orphan drug Yes
Registration phase Registration application pending

Therapeutic value

Therapeutic value No estimate possible yet
Substantiation De resultaten van de fase III HERIZON-GEA-01 studie zijn nog niet bekend.
Frequency of administration 1 times every 2 weeks
Dosage per administration 20 mg/kg
References NCT04466891 (HERIZON-BTC-01); NCT05152147 (HERIZON-GEA-01).

Expected patient volume per year

Patient volume

11 - 44

Market share is generally not included unless otherwise stated.
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

There is currently nothing known about the expected cost.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.