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Two-Arm, Randomized (2:1), Open-Label Phase II/III Study in EpCAM Positive Cancer Patients With Symptomatic Malignant Ascites Using the Trifuncitonal Bispecific Antibody Removab (Anti-EpCAM x Anti-CD3) Versus an Untreated Control Group.

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Two-Arm, Randomized (2:1), Open-Label Phase II/III Study in EpCAM Positive Cancer Patients With Symptomatic Malignant Ascites Using the Trifuncitonal Bispecific Antibody Removab (Anti-EpCAM x Anti-CD3) Versus an Untreated Control Group.

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 26 Nov 2024

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At a glance

  • Drugs Catumaxomab (Primary)
  • Indications Breast cancer; Cancer; Gastric cancer; Malignant ascites; Ovarian cancer; Solid tumours
  • Focus Registrational; Therapeutic Use

    • Most Recent Events

    • 19 Nov 2024 According to a Pharmanovia media release, Pharmanovia partners with Lindis biotech to commercialise catumaxomab for the treatment of rare condition, malignant ascites. EU marketing authorization for catumaxomab for the treatment of malignant ascites is expected by the end of 2024.
    • 18 Oct 2024 According to Lindis Biotech media release, the company announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the approval of KORJUNY (catumaxomab) for the intraperitoneal treatment of malignant ascites (MA) in adults with EpCAM-positive carcinomas who are not eligible for further systemic anticancer therapy based upon this study.
    • 24 Jun 2012 Quality-of-life results published in the Annals of Oncology.

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