MabCampath - alemtuzumab

PLEASE NOTE: MEDICINAL PRODUCT IS NO LONGER AUTHORIZED

What is MabCampath?

MabCampath is a concentrate in solution for intravenous infusion (drip into a vein). MabCampath contains the active substance alemtuzumab (10 mg / ml or 30 mg / ml).

What is MabCampath used for?

MabCampath is an anticancer medicine, indicated for the treatment of patients with chronic lymphocytic leukemia (LLC). CLL is a cancer of the lymphocytes (a type of white blood cell). MabCampath is used in patients who do not adapt combined therapies including fludarabine (another medicine used to treat leukemia).

The medicine can only be obtained with a prescription.

How is MabCampath used?

MabCampath should be administered under the supervision of a doctor experienced in the use of cancer therapy. Patients should be given steroids, an antihistamine and a painkiller before the initial dose and before each dose increase. Furthermore, antibiotic and antiviral medicines should be administered during therapy and after therapy.

MabCampath is given as an infusion lasting about two hours. During the first week of treatment, MabCampath should be administered in increasing doses: 3 mg on day 1, 10 mg on day 2 and 30 mg on day 3, provided that each dose is well tolerated. This mode of administration is called "dose intensification". Thereafter, the recommended dose is 30 mg a day, administered three times a week (every other day), up to a maximum of 12 weeks.

Patients should be monitored during treatment both to observe their response and to monitor the blood levels of platelets (the constituents of the blood that help coagulation) and neutrophils (the white blood cells that fight infection): if they are too low, the treatment must be suspended or interrupted. For further details, please refer to the Summary of Product Characteristics (also included with the EPAR).

How does MabCampath work?

Alemtuzumab, the active ingredient in MabCampath, is a monoclonal antibody. A monoclonal antibody is an antibody (a type of protein) designed to recognize and bind to a specific structure (called an antigen) present in certain cells in the body. Too many lymphocytes are produced in the CLL. Alemtuzumab was designed to bind to a glycoprotein (a coated protein

with sugar molecules) called CD52 which is found on the surface of lymphocytes. Following the binding, the lymphocyte dies and in this way the LLC is kept under control.

What studies have been carried out on MabCampath?

MabCampath has been studied in four main studies, on a total of 446 patients with CLL. One study involved 297 previously untreated patients. The study compared the effectiveness of a twelve-week treatment with MabCampath with that of a one-year treatment with chlorambucil (another anticancer medicine). The main measure of effectiveness was the time interval to progression of the disease or the patient's death.

The other three studies involved a total of 149 patients who had already received other treatments. In these studies, MabCampath was not compared to other treatments. The main study involved 93 patients who no longer responded to fludarabine treatment. The main measure of effectiveness was the overall response to treatment.

What benefit has MabCampath shown during the studies?

In patients who had not received any previous treatment, MabCampath was more effective than chlorambucil. For patients treated with MabCampath, the mean intercurrent interval before the worsening of the disease or the patient's death was 14.6 months, compared to 11.7 months for patients treated with chlorambucil. In the main study conducted on previously treated patients, the percentage of patients who responded partially or completely to treatment with MabCampath was 33%. Similar results were observed in the other two studies conducted on previously treated patients.

What is the risk associated with MabCampath?

Undesirable effects occur in approximately 97% of previously untreated patients and in about 80% of those previously treated. The most common side effects (seen in more than 1 patient in 10) are: infections, hypotension (low blood pressure), nausea, hives, rash, fever, chills, low blood cell content (granulocytes, platelets and red blood cells), anorexia (loss of appetite), headache, dyspnoea (difficulty breathing), vomiting, diarrhea, itching, hyperhidrosis (excessive sweating) and fatigue. For the full list of all side effects reported with MabCampath, see the Package Leaflet.

MabCampath should not be used in people who may be hypersensitive (allergic) to alemtuzumab, mouse proteins or any of the other components. MabCampath should not be used in patients:

1. with active infection, which has spread throughout the body;
2. with HIV infection;
3. who have active secondary tumors;
4. pregnant.

Why has MabCampath been approved?

The Committee for Medicinal Products for Human Use (CHMP) concluded that the efficacy of MabCampath has been demonstrated, although there are no reports of studies that have directly compared MabCampath with combined treatments, including fludarabine, widely used to treat patients with CLL. The CHMP therefore decided that the benefits of MabCampath outweigh its risks in the treatment of B-cell CLL patients for whom chemotherapeutic treatment with fludarabine is not suitable. The committee recommended the granting of the marketing authorization for MabCampath.

The authorization of MabCampath was initially issued in "exceptional circumstances" because, for scientific reasons, it was not possible to obtain complete information on the medicine. Since the pharmaceutical company provided the additional information requested, the aforementioned condition expired on 4 July 2008.

What measures are being taken to ensure the safe use of Mabcampath?

The pharmaceutical manufacturer of MabCampath will provide a brochure containing information on the safety of the medicine to all doctors in all Member States who prescribe MabCampath.

More information on MabCampath:

On 6 July 2001, the European Commission granted a marketing authorization for MabCampath, valid throughout the European Union, to Genzyme Europe BV. The marketing authorization was renewed on 6 July 2006.