LINDIS Biotech Achieves Key Milestone for Cancer Treatment in Europe

Lindis Biotech GmbH has announced a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) regarding KORJUNY® (catumaxomab) for treating malignant ascites in adults with EpCAM-positive carcinomas in the EU. Once authorized by the European Commission, KORJUNY® will be the sole approved treatment for this condition.

Clinical studies have indicated that KORJUNY®, administered with paracentesis, significantly extends puncture-free survival compared to paracentesis alone. The decision by the European Commission is anticipated by the end of 2024 and will have implications across EU member states, Iceland, Liechtenstein, and Norway.

Catumaxomab, the first bispecific trifunctional antibody for cancer, was initially approved in 2009, demonstrating its safety and efficacy in over 2000 patients. Lindis Biotech aims to explore its potential for other indications, such as bladder cancer, leveraging promising clinical data.