Korjuny
Authorised
This medicine is authorised for use in the European Union
catumaxomab
Medicine
Human
Authorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Korjuny is a medicine used to treat adults with malignant ascites (a build-up of fluid in the abdomen) caused by cancers that are EpCAM-positive (meaning that the cancer cells have a molecule on their surface called epithelial cellular adhesion molecule). Korjuny is used in patients who cannot have any further cancer treatment.
Korjuny contains the active substance catumaxomab.
The medicine can only be obtained with a prescription and should be given under the supervision of a doctor experienced in the use of cancer medicines. Before starting treatment, patients should be tested to ensure that the cancer cells are EpCAM-positive.
Korjuny is given by perfusion (a slow injection using a pump) into the abdomen (belly) over at least 3 hours, on days 0, 3, 7 and 10 of treatment. After the first dose, patients must remain in hospital for 24 hours to be monitored for certain side effects. For subsequent doses, patients must stay in hospital for 6 hours or longer if the doctor deems it necessary.
Korjuny can cause inflammatory reactions including cytokine release syndrome (CRS, a condition that can cause fever, nausea, vomiting, pain and low blood pressure) and systemic inflammatory response syndrome (SIRS, inflammation throughout the body). Before each infusion, it is recommended that patients take medicines against pain, fever and inflammation to prevent symptoms of inflammation in the body.
For more information about using Korjuny, see the package leaflet or contact your doctor or pharmacist.
The active substance in Korjuny, catumaxomab, is a monoclonal antibody (a type of protein) designed to recognise and attach to 2 proteins: EpCAM, a molecule found on certain cancer cells, and CD3, a protein found on T cells, a type of cell of the immune system (the body’s natural defences). By bringing cancer cells and T cells close together, catumaxomab promotes the killing of cancer cells by T cells. Catumaxomab also attaches to a third protein called Fc-gamma receptor which helps the cells of the immune system to attack cancer cells.
All these actions cause the death of cancer cells in the abdomen, removing a major cause of excessive abdominal fluid.
Korjuny was shown to prolong the time patients with malignant ascites caused by EpCAM-positive cancers live without requiring further paracentesis (a procedure in which a needle is inserted in the abdomen to drain fluid).
A main study involved 258 patients with malignant ascites and EpCAM-positive cancer who had either been previously treated with chemotherapy or for whom chemotherapy was not a suitable treatment. Patients given Korjuny and paracentesis lived for an average of 46 days without the need for further paracentesis, compared with 11 days for patients treated with paracentesis alone.
For the full list of side effects and restrictions with Korjuny, see the package leaflet.
The most common side effects with Korjuny (which may affect more than 1 in 10 people) include fever, abdominal pain, nausea (feeling sick) and vomiting.
The most important side effects with Korjuny include SIRS and liver failure.
Although there was some uncertainty about the beneficial effect of Korjuny, the overall data show that Korjuny prolongs the time adults with malignant ascites caused by EpCAM-positive cancers live without the need for paracentesis, indicating lower fluid build-up after treatment with Korjuny.
Regarding quality of life, Korjuny may alleviate symptoms of the disease shortly after treatment but giving the medicine requires hospitalisation. Concerning safety, side effects occur more frequently with Korjuny than with paracentesis only, with symptoms of inflammation (nausea, vomiting and fever) and abdominal pain being the most common. The safety profile of Korjuny was however considered acceptable for the condition it is used for.
The European Medicines Agency therefore decided that Korjuny’s benefits are greater than its risks and it can be authorised for use in the EU.
The company that markets Korjuny will provide patients with a patient card including information on the signs and symptoms of CRS and SIRS and when to seek urgent help from a healthcare professional. The patient card will also inform healthcare professionals that the patient is being treated with Korjuny and provide the contact details of the prescribing doctor.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Korjuny have also been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Korjuny are continuously monitored. Suspected side effects reported with Korjuny are carefully evaluated and any necessary action taken to protect patients.
Korjuny received a marketing authorisation valid throughout the EU on 10 February 2025.
Product information
Latest procedure affecting product information:VR/0000297256
23/09/2025
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Korjuny
- Active substance
- catumaxomab
- International non-proprietary name (INN) or common name
- catumaxomab
- Therapeutic area (MeSH)
- Ascites
- Anatomical therapeutic chemical (ATC) code
- L01FX03
Pharmacotherapeutic group
Antineoplastic agentsTherapeutic indication
Korjuny is indicated for the intraperitoneal treatment of malignant ascites in adults with epithelial cellular adhesion molecule (EpCAM)-positive carcinomas, who are not eligible for further systemic anticancer therapy.
News on Korjuny
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