Removab - catumaxomab

What is Removab?

Removab is a concentrate that is made up into a solution for infusion (drop by drop). The active ingredient contained in it is catumaxomab.

What is Removab used for?

Removab is used to treat malignant ascites, a buildup of fluid in the peritoneal cavity (space in the abdomen) caused by cancer. The medicine is used when standard treatment is unavailable or when standard treatment is no longer practicable.
Removab can only be used in patients with EpCAM-positive carcinomas, that is, for those tumors characterized by a massive presence of a molecule called EpCAM on the surface of the tumor cells.
The medicine can only be obtained with a prescription.

How is Removab used?

Removab treatment should only be administered under the supervision of a physician experienced in the use of anticancer medicines.
Removab is administered by intraperitoneal infusion (ie into the peritoneal cavity) via a pump system, usually with four infusions at increasing doses from 10 to 150 micrograms over 11 days. At least two days should elapse between infusions. however the interval may be extended in case of undesirable effects. The total duration of treatment should not exceed 20 days.
Patients should be monitored after each infusion. Removab must not be administered all at once or by multiple routes. Prior to treatment, it is recommended that the patient be given medications for pain, fever and inflammation. Patients with severe liver problems or moderate or severe kidney problems should only be treated with Removab after careful consideration of the risks and benefits of the medicine. Removab is not recommended for use in young people below 18 years of age due to a lack of information on safety and efficacy for this age group.

How does Removab work?

In cancer patients, ascites forms because cancer cells develop on the peritoneum, the membrane around the peritoneal cavity, blocking the natural drainage of fluids from the abdomen.
The active substance in Removab, catumaxomab, is a monoclonal antibody. A monoclonal antibody is an antibody (a type of protein) made to recognize a specific structure (called an antigen) present on certain cells in the body and attach to it. Catumaxomab has been designed to bind to two antigens: EpCAM, present at high levels on some types of cancer cells, and CD3, present in T cells. T cells are part of the immune system (the natural defenses of "organism) and are involved in coordinating the death of infected and abnormal cells. By binding to these two antigens, catumaxomab forms a bridge between cancer cells and T cells, which brings the cells together so that the T cells can neutralize the cancer cells. Catumaxomab also binds to a third substance, called the Fc-gamma receptor, which helps the body's immune system focus on cancer cells.

How has Removab been studied?

The effects of Removab were first tested in experimental models before being studied in humans.
Removab was the subject of a main study involving 258 patients with malignant ascites caused by EpCAM-positive cancer and for whom standard therapy was not available or no longer practicable. In this study, Removab, used in combination with the drainage of fluids from the abdomen, was compared with the use of drainage alone. The main measure of effectiveness was how long the patients survived without the need for additional drainage.

What benefit has Removab shown during the studies?

The combination of Removab and drainage was found to be more effective than drainage alone in the treatment of malignant ascites. On average, patients treated with Removab were able to live for 46 days without the need for additional drainage compared to 11 days for patients treated with drainage alone.

What is the risk associated with Removab?

90% of Removab treated patients experienced side effects. The most common side effects associated with Removab (i.e. seen in more than 1 in 10 patients) are lymphopenia (low level of lymphocytes, a type of white blood cell), abdominal pain, nausea, vomiting, diarrhea, pyrexia (fever), fatigue, chills and pains. For the full list of side effects reported with Removab, see the package leaflet.
Removab should not be used in patients who may be hypersensitive (allergic) to catumaxomab, to mouse or rat proteins or to any of the other ingredients.

Why has Removab been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Removab's benefits are greater than
its risks in the intraperitoneal treatment of malignant ascites in patients with EpCAM-positive carcinoma for whom standard therapy is not available or no longer practicable. The committee recommended the granting of a marketing authorization for Removab.

Other information about Removab:

On April 20, 2009, the European Commission granted Fresenius Biotech GmbH a "Marketing Authorization" for Removab, valid throughout the European Union.
For the full version of Removab's EPAR, click here.

Last update of this summary: 03-2009.

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