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Catumaxomab

Korjuny

Extended indication Indicated for the treatment of malignant ascites
Therapeutic value No estimate possible yet
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
Proprietary name Korjuny
Manufacturer Lindis
Mechanism of action Immunostimulation
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional remarks Positieve CHMP opinie oktober 2024

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date August 2022
Expected Registration January 2025
Orphan drug Yes
Registration phase Positive CHMP opinion
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
Substantiation Op dit moment lopen de studies nog.
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.
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

There is currently nothing known about the expected cost.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.