MHRA approves catumaxomab to treat cancer-related fluid build-up in the abdomen

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved catumaxomab (Korjuny) to treat malignant ascites in adults when standard treatment of their cancer is no longer feasible.

Malignant ascites is a build-up of fluid containing cancer cells in the abdomen. Patients often need procedures to drain this fluid. Catumaxomab provides a treatment option that can extend the time between patients requiring further drainage.

Catumaxomab is a monoclonal antibody, a type of protein that binds to specific targets on cells. It recognises a protein called epithelial cell adhesion molecule (EpCAM), which is found on the surface of certain cancer cells, including those in ascitic fluid. It activates cells of the immune system to help destroy these cancer cells.

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.

A main clinical study involved 258 patients with malignant ascites and EpCAM-positive cancer who had no further chemotherapy options or for whom chemotherapy was unsuitable. Patients receiving catumaxomab after paracentesis - a procedure to drain abdominal fluid - did not require further drainage for around 46 days, compared with 11 days for patients treated with paracentesis alone.

Catumaxomab is administered under the supervision of a doctor experienced in treating cancer. It is given through a catheter directly into the abdominal cavity as four infusions, with the dose increased at each infusion.

Common side effects include nausea, vomiting, diarrhoea, abdominal pain, fever, chills, fatigue and cytokine release syndrome, an inflammatory reaction caused by activation of the immune system.

Healthcare professionals and patients are encouraged to report suspected side effects through the MHRA's Yellow Card scheme.

• The new marketing authorisations were granted on 2 October to Atnahs Pharma UK Limited.

• This application was approved under the International Recognition Procedure.

• More information can be found in the Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL), which will be published on the MHRA Products website within 7 days of approval.

• The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.

• The MHRA is an executive agency of the Department of Health and Social Care.

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