Zolbetuximab Medicine 07 December 2021 Extended indication In combination with platinum- and fluoropyrimidine-based chemotherapy as first-line treatment of adult patients with locally advanced unresectable and/or metastatic adenocarcinoma of the stomach and gastro-esophageal junction that is HER2- and CLDN18.2+ (≥75% of tumor cells) as determined by a validated assay. Therapeutic value Possible added value Total cost Registration phase Registration application pending Product Active substance Zolbetuximab Domain Oncology Reason of inclusion New medicine (specialité) Main indication Stomach cancer Extended indication In combination with platinum- and fluoropyrimidine-based chemotherapy as first-line treatment of adult patients with locally advanced unresectable and/or metastatic adenocarcinoma of the stomach and gastro-esophageal junction that is HER2- and CLDN18.2+ (≥75% of tumor cells) as determined by a validated assay. Current proprietary name Already available biosimilars / generics Proprietary name Vyloy Manufacturer Astellas Portfolio holder Astellas Mechanism of action Immunostimulation Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date June 2023 Expected Registration September 2024 Orphan drug Yes Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Fabrikant verwacht indiening in juni 2023 en registratie in september 2024. Therapeutic value Current treatment options Huidige behandelopties zijn CAPOX / mFOLFOX. Therapeutic value Possible added value This assessment does not indicate any potential inclusion in the package. Substantiation First in class, nieuwe target therapie. Duration of treatment Frequency of administration 1 times every 3 weeks Dosage per administration 600-800 mg/m2 References NCT03653507 Additional remarks Expected patient volume per year Patient volume 75 - 100 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR; (record avelumab) Additional remarks Het aantal patiënten dat eerste lijn systemische therapie heeft gehad voor onresectable locally advanced of gemetastaseerd voor adenocarcinoom van de maag of gastro-oesofageale overgang lag tussen 2015 en 2017 tussen de 330 en 350 patiënten per jaar. Vaak worden geneesmiddelen die initieel zijn goedgekeurd voor deze groep ook ingezet voor patiënten met adenocarcinoom van de slokdarm. Dit zou betekenen dat er in totaal ongeveer 260 tot 290 patiënten per jaar in aanmerking komen voor deze behandeling. Er is in te schatten dat 25 tot 30% van de patiënten voldoende expressie van CLAUDINE 18.2 heeft voor behandeling aan de hand van de aanname uit de MONO studie. Er zullen dan 75 tot 100 patiënten in aanmerking komen. 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 Yes Indication extensions Pancreas References Additional remarks 2026 Other information Additional remarks