Zolbetuximab Medicine 07 December 2021 Extended indication Vyloy, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adult patients with locally advanced unresectable or metastatic HER2‑negative gastric or gastro-oesophageal junction (GEJ) adenocarcinoma whose tumours are Claudin (CLDN) 18.2 positive Therapeutic value Possibly no place in the treatment regimen Total cost Registration phase Registered Product Active substance Zolbetuximab Domain Oncology Reason of inclusion New medicine (specialité) Main indication Stomach cancer Extended indication Vyloy, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adult patients with locally advanced unresectable or metastatic HER2‑negative gastric or gastro-oesophageal junction (GEJ) adenocarcinoma whose tumours are Claudin (CLDN) 18.2 positive 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 Registered Reimbursement Medicine sluice Additional remarks Positieve CHMP opinie juli 2024 en EC decision in september 2024 Therapeutic value Current treatment options Huidige behandelopties zijn CAPOX / mFOLFOX. Therapeutic value Possibly no place in the treatment regimen This assessment does not indicate any potential inclusion in the package. Substantiation First in class, nieuwe target therapie. Er was een reductie van overlijden ten opzichte van placebo (HR 0,75, 95% CI 0·60–0·94; p=0·0053). De paskwil-criteria zijn niet gehaald. 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 (1) NKR; (record avelumab); (2) A multicentre, phase IIa study of zolbetuximab as a single agent in patients with recurrent or refractory advanced adenocarcinoma of the stomach or lower oesophagus: the MONO study - PMC (nih.gov) Additional remarks (1) 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. (2) Volgens de aanname in MONO studie heeft 31% van de patiënten voldoende expressie van CLAUDINE 18.2 voor behandeling. 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