Evoltra Overview

This is a summary of the European public assessment report (EPAR) for Evoltra. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Evoltra.

Evoltra treatment should be started and supervised by a doctor who has experience in the management of patients with acute leukaemias. The recommended dose is 52 mg per square metre of body surface area (calculated using the patient’s height and weight). It is given by infusion lasting two hours every day for five days. The treatment should be repeated every two to six weeks. Most patients who respond to treatment do so after one or two treatment cycles.

For further information see the package leaflet.

The active substance in Evoltra, clofarabine, is a cytotoxic (a medicine that kills cells that are dividing, such as cancer cells). It belongs to the group of cancer medicines called ‘antimetabolites’. Clofarabine is an ‘analogue’ of adenine, which is part of the fundamental genetic material of cells (DNA and RNA). This means that clofarabine takes the place of adenine in the body, and interferes with the enzymes involved in making genetic material, called ‘DNA polymerase’ and ‘RNA reductase’. This stops the cells making new DNA and RNA, and slows down the growth of tumour cells.

In the main study, 20% of the patients went into remission (12 out of 61). Overall, the patients in the study survived for an average of 66 weeks.

After treatment with Evoltra, 10 patients were able to go on to have a stem-cell transplant. This is a complex procedure where the patient receives stem cells from a matched donor to help restore the bone marrow. Stem cells are cells that can develop into different types of cell.

Patients with ALL who have not responded to or who have relapsed after receiving at least two treatments have a very poor chance of survival. The CHMP concluded that Evoltra treatment may provide a way of obtaining remission, and of facilitating a stem cell transplant. The Committee decided that Evoltra’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Evoltra has been authorised under ‘exceptional circumstances’. This means that, because the disease is rare, it has not been possible to obtain complete information about Evoltra. Every year, the European Medicines Agency will review any new information that may become available and this summary will be updated as necessary.

A risk management plan has been developed to ensure that Evoltra is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Evoltra, including the appropriate precautions to be followed by healthcare professionals and patients.

The European Commission granted a marketing authorisation valid throughout the European Union for Evoltra on 29 May 2006.

For more information about treatment with Evoltra, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

What are the risks associated with Evoltra?

The most common side effects with Evoltra (seen in more than 1 patient in 10) were febrile neutropenia (low white blood cell counts with fever), anxiety, headache, flushing (reddening of the face), vomiting, diarrhoea, nausea (feeling sick), palmar-plantar erythrodysaesthesia syndrome (rash and numbness on the palms and soles), pruritus (itching), pyrexia (fever), mucosal inflammation (inflammation of the moist body surfaces, such as the lining of the mouth) and fatigue (tiredness). 

Evoltra must not be given to patients with severe kidney or liver disease. Breast-feeding should be stopped before, during and after treatment with Evoltra. 

Owner of copyright and other intellectual property rights to European Medicines Agency

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