Catumaxomab--trifunctional anti-EpCAM antibody used to treat malignant ascites.

IMPORTANCE OF THE FIELD: Malignant ascites is a sign of advanced tumour growth and is associated with significant morbidity and a poor prognosis with a median survival time of a few months. Paracentesis is a recommended treatment for malignant ascites, but can cause complications, for example infections, injury of abdominal organs, persistent leakage of ascites, and haematoma/haemorrhage. The European Medicines Agency (EMA) approved the use of a trifunctional bispecific antibody, catumaxomab (Removab), for the intraperitoneal (i.p.) treatment of malignant ascites in April 2009. AREAS COVERED IN THIS REVIEW: This review describes the tailored preclinical and the clinical development of catumaxomab for the i.p. treatment of malignant ascites from 1998 to 2009. WHAT THE READER WILL GAIN: Relevant toxicology and pharmacokinetic findings are reported as well as main results of a large international Phase II/III study that was pivotal in the EMA approval of catumaxomab. TAKE HOME MESSAGE: Catumaxomab i.p. treatment results in a significant and clinically relevant improvement of puncture-free survival time and time to first need for puncture compared with paracentesis alone. The related side effects of catumaxomab treatment are predictable and related to the antibody's mode of action.