Regulators have approved a new medicine for adults with malignant ascites, a condition in which fluid containing cancer cells collects in the abdomen. The Medicines and Healthcare products Regulatory Agency (MHRA) granted the authorisation for catumaxomab, sold as Korjuny, according to the agency's announcement.
Key points
- What it treats — malignant ascites in adults once standard cancer treatment is no longer an option.
- How it works — a monoclonal antibody that targets EpCAM on certain cancer cells and calls in the immune system.
- Trial result — patients given the drug after drainage went around 46 days before needing another procedure, against 11 days with drainage alone.
- Who holds it — marketing authorisations were granted on 2 October to Atnahs Pharma UK Limited.
Malignant ascites often means repeated hospital visits to have fluid drained from the abdomen, a procedure known as paracentesis. Catumaxomab is designed to stretch out the time between those procedures.
The drug is a monoclonal antibody, a protein that latches onto a specific target on cells. In this case it recognises epithelial cell adhesion molecule (EpCAM), found on the surface of some cancer cells, including those in ascitic fluid, and triggers immune cells to attack them.
A key study looked at 258 patients with malignant ascites and EpCAM-positive cancer who had run out of chemotherapy options or could not tolerate it. Those who received catumaxomab after paracentesis avoided further drainage for roughly 46 days, compared with 11 days for those who had only the drainage procedure.
Julian Beach, the MHRA's Interim Executive Director of Healthcare Quality and Access, said malignant ascites can be a heavy burden for people living with cancer, especially when few treatments remain. He added that the approval gives another option that can extend the time patients go without needing their abdomen drained again, and that the regulator will keep watching the medicine's safety. Suspected side effects should be reported through the Yellow Card scheme, he said.
The medicine is given by a doctor experienced in cancer care, through a catheter into the abdominal cavity. It comes as four infusions, with the dose rising each time. Commonly reported side effects include nausea, vomiting, diarrhoea, abdominal pain, fever, chills, fatigue and cytokine release syndrome, an inflammatory reaction from immune system activation.
The application was approved under the International Recognition Procedure. More detail will appear in the Summary of Product Characteristics and the Patient Information Leaflet, due on the MHRA Products website within seven days of approval.
What it means in practice
For patients and families dealing with malignant ascites, this is a extra option rather than a cure, and it will not appear in GP surgeries or pharmacies. The drug is given in hospital by cancer specialists, so the practical change is in referral and treatment planning, not in something you can ask for over the counter.
- Ask the care team — if you or a relative has ascites and chemotherapy is no longer working, it is worth asking the oncology team whether this treatment is suitable.
- Keep reporting side effects — the MHRA is still monitoring the medicine, so patients and clinicians should use the Yellow Card scheme.
- Watch for the paperwork — the official product information and patient leaflet will be published on the MHRA Products website within a week of approval.
