Korjuny
Oncology· 133 cited findings· 1 source document
Company: Atnahs B V
What the regulatory reviews say
Korjuny is indicated for the intraperitoneal treatment of malignant ascites in adults with epithelial cellular adhesion molecule (EpCAM)-positive carcinomas who are not eligible for further systemic anticancer therapy. The marketing authorisation application was submitted on 1 August 2022, with a positive opinion date of 17 October 2024. However, the marketing authorisation status is a refusal of the granting.
Key efficacy findings include a median puncture-free survival of 35 days. In comparative data, the median time to puncture for catumaxomab was 102 days, while for catumaxomab + prednisolone it was 78 days. The hazard ratio for time to puncture (catumaxomab vs catumaxomab + prednisolone) was 0.901. Daily fluid production was observed to be 3.3 to 7.0 times lower. The median time to first deterioration in quality of life ranged from 19–26 days to 47–49 days.
Regarding safety, the incidence of pyrexia was 62.16%, abdominal pain was 42.47%, nausea was 40.73%, and vomiting was 38.22%. The incidence of pain was 10.23%. Patients experiencing grade ≥3 adverse events ranged from 29.5% to 80%. HAMA prevalence was 2.02% and HARA prevalence was 17.17%.
Key figures — cited to the source page
| Median puncture-free survival | 35 | Atnahs B V — Korjuny EMA EPAR public assessment report (EMEA, p.102 |
| Median time to puncture for catumaxomab | 102 | Atnahs B V — Korjuny EMA EPAR public assessment report (EMEA, p.48 |
| Median time to puncture for catumaxomab + prednisolone | 78 | Atnahs B V — Korjuny EMA EPAR public assessment report (EMEA, p.48 |
| Hazard ratio for time to puncture (catumaxomab vs catumaxomab + prednisolone) | 0.901 | Atnahs B V — Korjuny EMA EPAR public assessment report (EMEA, p.48 |
| Pyrexia incidence | 62.16 | Atnahs B V — Korjuny EMA EPAR public assessment report (EMEA, p.111 |
| Patients with grade ≥3 AEs | 29.5 | Atnahs B V — Korjuny EMA EPAR public assessment report (EMEA, p.107 |
| Marketing authorisation positive opinion date | 17 October 2024 | Atnahs B V — Korjuny EMA EPAR public assessment report (EMEA, p.9 |
| Marketing authorisation status | refusal of the granting | Atnahs B V — Korjuny EMA EPAR public assessment report (EMEA, p.143 |
Source documents
Explore the full evidence
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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.