Catumaxomab Medicine 07 December 2022 Extended indication Advanced Gastric Cancer with Peritoneal Metastasis Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Catumaxomab Domain Oncology Reason of inclusion New medicine (specialité) Main indication Stomach cancer Extended indication Advanced Gastric Cancer with Peritoneal Metastasis Current proprietary name Already available biosimilars / generics Proprietary name Removab Manufacturer Neovii Portfolio holder Mechanism of action Immunostimulation Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Bispecific antibody. Dit geneesmiddel is eerder teruggetrokken voor de indicatie maligne ascites. Ook door de cieBOM is vastgesteld dat het niet is aangetoond dat catumaxomab een klinisch relevante meerwaarde heeft in de behandeling van patiënten met deze indicatie. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date August 2022 Expected Registration September 2023 Orphan drug Yes Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Primary completion datum fase 2 studie in januari 2023. Therapeutic value Current treatment options Cytoreductieve chirurgie (CR) en hypertherme intraperitoneale chemotherapie (HIPEC) Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Op dit moment lopen de studies nog. Duration of treatment Frequency of administration Dosage per administration References NCT04222114 Additional remarks The starting dose of catumaxomab for intra-peritoneal infusion will be 10μg, gradually increased to 20μg, 50μg and 150μg, respectively. From the second cycle, catumaxomab will be changed to 20μg,50μg,150μg on days 1,4 and 8. Expected patient volume per year Patient volume 106 - 215 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References A Rijken. The Burden of Peritoneal Metastases from Gastric Cancer: A Systematic Review on the Incidence, Risk Factors and Surviva. 2021l(1); NKR2020(2); Additional remarks Peritoneale metastasen (CPM) komen voor in 10-21% van de patiënten die een maagcarcinoom hebben (1). In 2020 waren er 1.063 patiënten met een maagcarcinoom (2). 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 Unknown Indication extensions References Additional remarks Other information Additional remarks