The Medicines and Healthcare products Regulatory Agency (MHRA) has approved catumaxomab (Korjuny) for the treatment of malignant ascites in adults whose underlying cancer can no longer be treated using standard options.
The decision offers new hope for patients living with advanced cancer who experience recurrent fluid build-up in the abdomen, a distressing condition that often requires repeated hospital procedures to drain excess fluid.
Malignant ascites occurs when cancer cells accumulate within fluid in the abdominal cavity, leading to swelling, discomfort, breathing difficulties and reduced quality of life. Patients frequently require paracentesis, a procedure that removes fluid from the abdomen, but repeat interventions are often necessary.
Catumaxomab has been approved to help extend the period between drainage procedures, potentially reducing the burden on patients and healthcare services.
The medicine is a monoclonal antibody designed to target epithelial cell adhesion molecule (EpCAM), a protein found on the surface of several cancer cell types, including those present in malignant ascites. By binding to EpCAM, catumaxomab activates immune cells to identify and destroy cancer cells within the abdominal fluid.
Approval follows evidence from a pivotal clinical study involving 258 patients with malignant ascites caused by EpCAM-positive cancers. The patients either had no remaining chemotherapy options or were considered unsuitable for further chemotherapy.
The findings demonstrated a significant improvement for patients treated with catumaxomab following paracentesis. Those receiving the therapy went an average of 46 days before requiring another drainage procedure, compared with just 11 days for patients who underwent paracentesis alone.
Julian Beach, MHRA Interim Executive Director of Healthcare Quality and Access, said:
“Malignant ascites can place a considerable burden on people living with cancer, particularly when further treatment options are limited.
“This approval provides an additional treatment option that can help extend the time patients live without needing another procedure to drain fluid from their abdomen.
“As with all medicines, we will continue to monitor catumaxomab’s safety closely. Anyone who experiences suspected side effects should report them through our Yellow Card scheme.”
Treatment must be given under the supervision of a clinician experienced in cancer care. Catumaxomab is delivered directly into the abdominal cavity through a catheter and is administered as a series of four infusions, with the dose increasing at each stage of treatment.
As with other immunotherapy treatments, catumaxomab can cause side effects. The most commonly reported adverse reactions include:
- Nausea
- Vomiting
- Diarrhoea
- Abdominal pain
- Fever
- Chills
- Fatigue
- Cytokine release syndrome
Cytokine release syndrome is an inflammatory response triggered by activation of the immune system and may require careful monitoring and management.
The MHRA has urged both patients and healthcare professionals to continue reporting suspected side effects through the Yellow Card scheme to support ongoing safety monitoring.
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