Safety concerns linked to Aranesp in cancer trial

The US Food and Drug Administration has issued an alert regarding the results of a clinical trial of US biotechnology major Amgen's Aranesp (darbepoetin alfa), under development as a treatment for cancer-related anemia. The agency reports that the drug did not reduce the need for transfusions in comparison with placebo, and that patients receiving it had a higher death rate than those in the control group.

The alert follows a similar warning issued by the FDA in November last year that arose after the publication of data from the CHOIR study. Those results showed that patients treated with an erythropoiesis-stimulating agent at a dosage designed to achieve a hemoglobin concentration of 13.5g/dl, had a significantly higher chance of developing serious cardiovascular complications than those dosed to reach a target concentration of 11.3g/dl.

In its most recent alert, the FDA reiterated that Aranesp has not been cleared as a treatment for anemia in cancer patients who are not receiving chemotherapy, and added that the findings may apply to other ESAs.