The European Commission has granted marketing authorization for catumaxomab, a trifunctional antibody, for the treatment of malignant ascites in adults with epithelial cellular adhesion molecule (EpCAM)-positive carcinomas who are ineligible for further systemic anticancer therapy. This approval marks a significant advancement in the management of this debilitating condition, offering a new therapeutic option where limited treatments are currently available.
Malignant ascites is a serious complication of advanced-stage cancers, characterized by the accumulation of fluid in the abdomen. This condition leads to symptoms such as abdominal distension, pain, shortness of breath, and fatigue, significantly impacting patients' quality of life. Current management strategies often involve invasive procedures like paracentesis, which provide temporary relief but carry risks of complications.
Novel Mechanism of Action
Catumaxomab is a first-in-class therapeutic that works by targeting tumor cells and engaging the patient’s own immune system. The antibody binds to EpCAM, a protein highly expressed on many cancer cells, and CD3, a T-cell receptor, forming a bridge that brings T-cells into close proximity with cancer cells, facilitating their destruction. Additionally, catumaxomab activates Fc-gamma receptor-positive immune cells, such as monocytes and macrophages, enhancing the immune response against the tumor.
Commercialization and Availability
Under a licensing agreement, Lindis Biotech has granted Pharmanovia exclusive rights to commercialize and launch catumaxomab across Europe. This partnership aims to ensure that this groundbreaking therapy becomes accessible to patients who can benefit from it. Catumaxomab was previously approved in the EU under the brand name Removab in 2009 but was withdrawn from the market in 2017 due to commercial reasons. The reintroduction of catumaxomab, now under the potential brand name Korjuny, addresses a critical unmet need in cancer supportive care.
Clinical Perspective
"This European Commission approval of catumaxomab is a significant milestone for people living with malignant ascites," said Stephen Deacon, Chief Scientific Officer at Pharmanovia. "Catumaxomab represents a novel therapeutic approach to this challenging condition. By targeting tumour cells and harnessing the power of the patient’s own immune system, we aim to improve quality of life for those living with malignant ascites in Europe."
Dr. Horst Lindhofer, CEO of Lindis Biotech, added, "We are delighted to receive marketing approval for catumaxomab. The approval highlights its potential to address the significant medical and treatment challenges faced by patients with malignant ascites...Partnering with Pharmanovia to support commercialization, we are committed to ensuring that this groundbreaking therapy becomes accessible to all patients who can benefit from it."
