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Bemarituzumab

Extended indication Eerstelijnsbehandeling bij niet-operabel, lokaal gevorderd of gemetastaseerd HER2- en FGFR2b+ maagka
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Bemarituzumab
Domain Oncology
Reason of inclusion New medicine (specialité)
Main indication Stomach cancer
Extended indication Eerstelijnsbehandeling bij niet-operabel, lokaal gevorderd of gemetastaseerd HER2- en FGFR2b+ maagkanker/gastro-esophageal junction kanker
Manufacturer Amgen
Portfolio holder Amgen
Mechanism of action Other, see general comments
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional remarks werkingsmechanisme: FGFR2b Monoklonaal antilichaam

Registration

Registration route Centralised (EMA)
ATMP No
Submission date 2025
Expected Registration 2026
Orphan drug No
Registration phase Clinical trials

Therapeutic value

Current treatment options Platinum bevattende chemotherapie (FOLFOX)
Therapeutic value No estimate possible yet
Substantiation De lopende fase 3 studie vergelijkt FOLFOX + bemarituzumab vs FOLFOX als 1e lijnsbehandeling. Tijdens de primaire analyse en bij een mediane follow-up van 10,9 maanden (IQR 6,3–14,2), was de mediane progressie-vrije survival 9,5 maanden (95% CI 7·3–12·9) in de bemarituzumab groep en 7,4 maanden (5·8–8·4) in de placebogroep (hazard ratio [HR] 0·68 [95% CI 0·44–1·04; p=0,073).
Frequency of administration 1 times every 2 weeks
Dosage per administration 15 mg/kg
References NCT05052801; Lancet Oncology oct 2022: Randomised, double-blind, placebo-controlled phase 2 trial (FIGHT)

Expected patient volume per year

References 1. IKNL; 2. Rapport Slokdarm en maagkanker in Nederland (https://iknl.nl/slokdarm-en-maagkanker); 3. Rapport kanker in Nederland in 2032 (IKNL 2023)
Additional remarks In 2022 waren er 1.102 maagkanker plus 452 GEJ/cardiakanker diagnoses. Stadium IV: 48% maagkanker + 38% GEJ/cardiakanker (totaal 701 patiënten). HER2-: ~80% (561 patiënten) FGFR2b overexpression >10%: 15-20% (84-112 patiënten) 33% maagkanker en 37% GEJ/cardiakanker patiënten krijgen systemische behandeling in 1L (29-38 patiënten)

Expected cost per patient per year

Additional remarks prijs onbekend

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

Off label use No

Indication extension

Indication extension Yes
Indication extensions 1e lijn behandeling in combinatie met platinum-bevattende chemotherapie en immuuntherapie
References https://clinicaltrials.gov/study/NCT05111626?cond=Gastric%20Cancer&intr=Bemarituzumab&aggFilters=phase:3&rank=2

Other information

There is currently no futher information available.