Atnahs B V — Korjuny EMA EPAR public assessment report (EMEA/H/C/005697, 2025)
Atnahs B V · 2025 · EMA EPAR public assessment report
Report summary
This report summarizes the marketing authorization application for Korjuny (catumaxomab) for treating malignant ascites in adults with EpCAM-positive carcinomas. It details the regulatory process, product quality, manufacturing, and non-clinical and clinical studies. Catumaxomab's mechanism involves targeting tumor and immune cells. Clinical trials showed prolonged puncture-free survival but a high incidence of severe adverse events (80% vs. 29.5% in control), including pyrexia and abdominal pain. Non-clinical studies faced challenges due to species-specific binding. Pharmacokinetic data revealed high anti-drug antibody development. The report outlines supply conditions, risk management, and a divergent CHMP opinion questioning the benefit-risk balance.
Key findings — cited to the page
| patients with grade ≥3 AEs | 77 % | · p.107 |
| patients with grade ≥3 AEs | 29.5 % | control group · p.107 |
| daily fluid production ratio | 3.3 times lower | ovarian cancer catumaxomab group vs control · p.102 |
| patients with grade ≥3 AEs | 80 % | · p.107 |
| daily fluid production ratio | 7.0 times lower | non-ovarian cancer catumaxomab group vs control · p.102 |
| reversible bilirubin elevation of CTC Grade 3 | 1 | STP-REM-01 · p.60 |
| Previous marketing authorisation date | 20 Apr 2009 | Removab · EU · p.12 |
| Dosing schedule | 10 micrograms on day 0, 20 micrograms on day 3, 50 micrograms on day 7, 150 micrograms on day 10 micrograms | Korjuny · p.12 |
| Marketing authorisation positive opinion date | 17 October 2024 | Korjuny · p.9 |
| Approved indication | intraperitoneal treatment of malignant ascites in adults with epithelial cellular adhesion molecule (EpCAM)-positive carcinomas, who are not eligible for further systemic anticancer therapy | Korjuny · p.12 |
| Marketing authorisation application submission date | 1 August 2022 | Korjuny · EU · p.7 |
| Previous marketing authorisation withdrawal date | 2 June 2017 | Removab · EU · p.12 |
Source: Atnahs B V ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →