Bemarituzumab Medicine 03 December 2024 Extended indication Eerstelijnsbehandeling bij niet-operabel, lokaal gevorderd of gemetastaseerd HER2- en FGFR2b+ maagkanker/gastro-esophageal junction kanker. Therapeutic value No estimate possible yet Total cost 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. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Amgen Portfolio holder Amgen Mechanism of action Other, see general comments Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Werkingsmechanisme: FGFR2b Monoklonaal antilichaam. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date September 2025 Expected Registration September 2026 Orphan drug Yes Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Tijdslijn op basis van informatie fabrikant. Therapeutic value Current treatment options Platinum bevattende chemotherapie (FOLFOX) of FOLFOX + nivolumab/pembrolizumab. Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation De lopende fase 3 studie vergelijkt FOLFOX + bemarituzumab versus 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). Duration of treatment 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) Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice 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 4: 48% maagkanker + 38% GEJ/cardiakanker (totaal 701 patiënten). HER2-: ongeveer 80% (561 patiënten) FGFR2b overexpression meer dan10%: 15 tot 20% (84 tot 112 patiënten) 33% maagkanker en 37% GEJ/cardiakanker patiënten krijgen systemische behandeling in 1L (29 tot 38 patiënten) Expected cost per patient per year Cost References Additional remarks prijs onbekend Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use No Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions Eerste 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 Additional remarks Other information Additional remarks Parallel aan de EMA procedure zal een beoordeling volgens de EU HTAR gedaan worden.