The Medicines and Healthcare products Regulatory Agency (MHRA) has granted approval for catumaxomab (Korjuny) as a treatment for malignant ascites in adults when conventional cancer treatments are no longer viable.
Malignant ascites refers to the accumulation of fluid containing cancer cells in the abdominal cavity, often necessitating procedures to drain this excess fluid. Catumaxomab presents a new therapeutic option that can prolong the intervals between necessary drainage procedures for patients.
Mechanism of Action
Catumaxomab is classified as a monoclonal antibody, a type of protein designed to bind to specific cellular targets. It specifically identifies a protein known as the epithelial cell adhesion molecule (EpCAM), which is present on the surface of certain cancer cells, including those found in ascitic fluid. By recognising this protein, catumaxomab activates immune system cells to assist in the destruction of cancer cells.
Julian Beach, the Interim Executive Director of Healthcare Quality and Access at the MHRA, commented on the significance of this approval, stating, “Malignant ascites can place a considerable burden on individuals living with cancer, especially when further treatment options are restricted. This approval offers an additional treatment avenue that can help extend the duration patients can live without the need for further procedures to drain fluid from their abdomen.”
Clinical Study Highlights
In a pivotal clinical trial, 258 patients suffering from malignant ascites and EpCAM-positive cancer—who had exhausted chemotherapy options or for whom such treatments were unsuitable—were studied. Those who received catumaxomab following paracentesis, a procedure used to drain abdominal fluid, experienced significantly longer periods without requiring additional drainage, averaging around 46 days compared to just 11 days for patients who underwent paracentesis alone.
Catumaxomab is administered under the guidance of a healthcare professional experienced in oncology. The treatment is delivered via catheter directly into the abdominal cavity, consisting of four infusions with increasing dosages at each session.
Possible Side Effects
As with any medication, catumaxomab may lead to side effects. Commonly reported adverse reactions include nausea, vomiting, diarrhoea, abdominal pain, fever, chills, fatigue, and cytokine release syndrome, an inflammatory response resulting from immune system activation.
Healthcare professionals and patients are encouraged to report any suspected side effects through the MHRA’s Yellow Card scheme to ensure ongoing safety monitoring.
Regulatory and Availability Information
On 2 October, the new marketing authorisations were assigned to Atnahs Pharma UK Limited under the International Recognition Procedure. Comprehensive details regarding catumaxomab will be made available in the Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL), which are expected to be published on the MHRA Products website within a week of the approval.
The MHRA plays a crucial role in regulating all medicines and medical devices in the UK, ensuring their efficacy and safety. The agency operates under a framework of thorough, evidence-based evaluations to confirm that the benefits of treatments outweigh any associated risks. As an executive agency of the Department of Health and Social Care, the MHRA is dedicated to enhancing public health standards across the nation.
For media inquiries, please reach out via email at newscentre@mhra.gov.uk or call 020 3080 7651.