Source: DGNews  |  Posted 3 years ago

LONDON -- June 27, 2008 -- The European Medicines Agency (EMEA) has recommended updating the product information for epoetin-containing medicines with a new warning for their use in patients with cancer stating that blood transfusion should be the preferred method of correcting anaemia in patients with cancer.

The Agency's Committee for Medicinal Products for Human Use (CHMP) had reviewed new data from studies that showed an increased risk of tumour progression, venous thromboembolism, and shorter overall survival in cancer patients who received epoetins compared with patients who did not receive them. Following this review, the CHMP concluded, at its June 2008 meeting, that the benefits of epoetins continue to outweigh their risks in the approved indications.

However, in patients with cancer with a reasonably long life expectancy, the benefit of epoetins does not outweigh the risk of tumour progression and shorter overall survival and therefore the Committee concluded that, in these patients, anaemia should be corrected with blood transfusions.

Physicians and patients are advised that the decision to administer epoetin-containing medicines should be based on an informed assessment of the benefits against the risks on an individual basis. The type and stage of tumour, the degree of anaemia, the patient's life expectancy, the environment in which the patient is being treated, and patient preference should be taken into account.

The Committee agreed that there is no consequence of the new information on the use of epoetin-containing medicines for the treatment of anaemia in patients with chronic renal failure.

The CHMP will continue to review the safety profile of the epoetins within the terms of their currently authorised indications in the European Union as additional data become available.

The CHMP also requested that the marketing authorisation holders for epoetin-containing medicines should carry out, as a priority, additional studies to clarify the risks and benefits of epoetins in the treatment of patients with cancer under the new treatment recommendations.

SOURCE: European Medicines Agency