CHMP positive fro Korjuny (catumaxomab) for treatment of malignant ascites
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Korjuny, intended for the intraperitoneal treatment of malignant ascites. The applicant for this medicinal product is Lindis Biotech GmbH
Korjuny will be available as 10 µg and 50 µg concentrate for solution for infusion. The active substance of Korjuny is catumaxomab, an antineoplastic agent (ATC code: L01FX03). Catumaxomab is a monoclonal antibody that targets the epithelial cell adhesion molecule (EpCAM) on tumour cells and CD3 antigen on T cells, inducing an immunoreaction against EpCAM expressing tumour cells. The benefit of Korjuny is its ability to reduce the need for paracenteses in patients with malignant ascites. The most common side effects are pyrexia, abdominal pain, nausea and vomiting.