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Amgen Highlights Key Clinical Data to be Presented at European Society for Medical Oncology Congress
Date:10/5/2010

hypertension.

Important European Product Safety Information For full prescribing information please see the Summary of Product Characteristics.

Aranesp is indicated for treatment of symptomatic anaemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy.

Aranesp is contraindicated in patients with poorly controlled hypertension.

Controlled clinical trials have not shown significant benefits attributable to the administration of epoetins when haemoglobin concentration is increased beyond the level necessary to control symptoms of anaemia and to avoid blood transfusion.

In controlled clinical studies, use of Aranesp and other ESAs have shown:

  • shortened time to tumour progression in patients with advanced head and neck cancer receiving radiation therapy when administered to target Hb > 14 g/dL; ESAs are not indicated for use in this patient population
  • shortened overall survival and increased deaths attributed to disease progression at 4 months in patients with metastatic breast cancer receiving chemotherapy when administered to target Hb 12-14 g/dL
  • increased risk of death when administered to target Hb of 12 g/dl (7.5 mmol/l) in patients with active malignant disease receiving neither chemotherapy nor radiation therapy; ESAs are not indicated for use in this patient population.

  • In some clinical situations blood transfusion should be the preferred treatment for the management of anaemia in patients with cancer. The decision to administer recombinant erythropoietins should be based on a benefit-risk assessment with the participation of the individual patient, which should take into account the specific clinical context. Factors that should be considered in this assessment should include the type of tumour and its stage; the degree of anaemia; life-expectancy; the environment in which the patient is being treated; and patient preference.

    In patients with so
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    SOURCE Amgen
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