The Medicines and Healthcare products Regulatory Agency (MHRA) has approved catumaxomab, marketed as Korjuny, for adults with malignant ascites when further standard cancer treatment is no longer feasible.
The medicine is intended for patients who develop malignant ascites, a condition in which cancer-associated fluid accumulates inside the abdomen.
Treatment targets cancer-related fluid build-up
Malignant ascites contains cancer cells and can require repeated procedures to remove the excess fluid.
Catumaxomab offers a treatment option designed to increase the period between these drainage procedures.
The medicine is a monoclonal antibody, a type of protein designed to recognise particular targets on cells.
Catumaxomab targets epithelial cell adhesion molecule (EpCAM), a protein present on the surface of some cancer cells, including cancer cells found in ascitic fluid.
By binding to EpCAM, the medicine activates immune cells, helping them identify and destroy the targeted cancer cells.
Clinical study examined time between drainage procedures
The approval was supported by a main clinical study involving 258 patients with malignant ascites and EpCAM-positive cancer.
Participants had either exhausted available chemotherapy options or were considered unsuitable for further chemotherapy.
Following paracentesis, the procedure used to drain fluid from the abdomen, patients who received catumaxomab went for about 46 days before requiring another drainage procedure.
Those who received paracentesis alone required another drainage procedure after about 11 days.
Catumaxomab is administered directly into the abdomen
Treatment is given under the supervision of a doctor with experience in cancer care.
Catumaxomab is administered through a catheter directly into the abdominal cavity.
The treatment consists of four infusions, with the dose increased at each stage.
Side effects listed for the medicine
Reported common side effects include nausea, vomiting, diarrhoea and abdominal pain.
Patients may also experience fever, chills and fatigue.
Cytokine release syndrome is also listed as a common side effect.
This is an inflammatory reaction associated with activation of the immune system.
MHRA will continue safety monitoring
Julian Beach, MHRA Interim Executive Director of Healthcare Quality and Access, said the approval gives patients with malignant ascites an additional treatment option when further cancer treatment is limited.
He also said the agency would continue to monitor the medicine’s safety and encouraged patients and healthcare professionals to report suspected side effects through the MHRA’s Yellow Card scheme.
The marketing authorisations for catumaxomab were granted to Atnahs Pharma UK Limited on 2 October under the International Recognition Procedure.
Information about the medicine, including its Summary of Product Characteristics and Patient Information Leaflet, is due to be published on the MHRA Products website within seven days of approval.
