Catumaxomab Medicine 07 December 2022 Extended indication Indicated for the treatment of malignant ascites Therapeutic value No estimate possible yet Total cost Registration phase Positive CHMP opinion Product Active substance Catumaxomab Domain Oncology Reason of inclusion New medicine (specialité) Main indication Oncology other Extended indication Indicated for the treatment of malignant ascites Current proprietary name Already available biosimilars / generics Proprietary name Korjuny Manufacturer Lindis Portfolio holder Mechanism of action Immunostimulation Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Positieve CHMP opinie oktober 2024 Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date August 2022 Expected Registration January 2025 Orphan drug Yes Registration phase Positive CHMP opinion Reimbursement Medicine sluice Additional remarks Positieve CHMP opinie oktober 2024 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 110 - 232 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR2021 (1); A Rijken. The Burden of Peritoneal Metastases from Gastric Cancer: A Systematic Review on the Incidence, Risk Factors and Surviva. 2021 (2); Expertopinie (3). Additional remarks In 2021 waren er 1.109 patiënten met een maagcarcinoom (1). Peritoneale metastasen (CPM) komen voor in 10 tot 21% van de patiënten die een maagcarcinoom hebben (2). Een deel van de patiënten komt in aanmerking voor chirurgie en overige patiënten alleen nog voor palliatieve chemotherapie. Het is onduidelijk voor welke groep patiënten catuxomab ontwikkeld wordt. Het aantal patiënten zal dus aan de lage kant van deze inschatting liggen (3). 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