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A phase III randomised, placebo-controlled study assessing the efficacy and safety of darbepoetin in cancer patients with anaemia not associated with chemotherapy has shown increased mortality in patients treated with this drug.
Amgen has notified the oncology medical community of the results of this trial. The study duration was 16 weeks, with a 16-week extension to enable further data on safety and effectiveness to be collected. Final analysis did not show a statistically significant effect of darbepoetin on the primary efficacy endpoint, with an incidence of red blood cell transfusions of 24% in the placebo vs 18% in the darbepoetin group. With a median survival follow-up of 4.3 months, the absolute number of deaths was found to be greater in the darbopoetin group (49% vs 46% in the placebo group). Follow-up for overall survival is continuing.
Amgen has stressed that darbepoetin is currently only approved for the treatment of patients with anaemia caused by chemotherapy.