Zolbetuximab Medicine 04 June 2026 Extended indication Zolbetuximab in combination With Nab-Paclitaxel and Gemcitabine (Nab-P + GEM) as First Line Treatment in Subjects With Claudin 18.2 (CLDN18.2) Positive, Metastatic Pancreatic Adenocarcinoma. Therapeutic value No estimate possible yet Total cost € 7,540,000.00 Registration phase Clinical trials Product Active substance Zolbetuximab Domain Oncology Reason of inclusion Indication extension IND Main indication Pancreatic cancer Extended indication Zolbetuximab in combination With Nab-Paclitaxel and Gemcitabine (Nab-P + GEM) as First Line Treatment in Subjects With Claudin 18.2 (CLDN18.2) Positive, Metastatic Pancreatic Adenocarcinoma. 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 Powder for solution for infusion Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks NCT03816163 (Phase 2 study) Registration Registration route Centralised (EMA) Type of trajectory Particularity ATMP No Submission date 2026 Expected Registration 2027 Orphan drug Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks NCT03816163 (Fase 2 studie) primaire voltooiingsdatum 31 augustus 2026). Therapeutic value Current treatment options Nab-Paclitaxel and Gemcitabine (Nab-P+GEM) of Folfirinox Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration References Additional remarks Expected patient volume per year Patient volume < 116 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References kanker.nl (2022), Alvleesklierkanker in Nederland (IKNL, nov 2021) Additional remarks Volgens kanker.nl werden in 2022 2878 patienten gediagnostiseerd met alvleesklierkanker. Daarvan was 58% (1670 patienten) gediagnostiseerd met stadium 4 (gemetastaseerde vorm) waarvan 25% wordt behandeld (417 patienten). 28% van deze patienten (116 patienten) hebben een hoge expressie van claudine 18.2 (> 75% +2/+3 positieve staining) en komen potentieel in aanmerking voor behandeling met zolbetuximab. Expected cost per patient per year Cost € 60,000.00 - 70,000.00 This amount gives an indication of the total cost. It is the result of the average expected patient volume times the average cost per patient. both per year. References medicijnkosten.nl Additional remarks De Apotheekinkoopprijs per flacon zolbetuximab (Vyloy) (100mg per vial): €539,95 (exclusief BTW). Behandelduur onbekend, klinische studie loopt nog. Mogelijk vergelijkbaar met andere indicaties Potential total cost per year Total cost € 7,540,000.00 Total cost for sluice Additional remarks Off label use Off label use Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks