On January 26, 2007 Amgen sent information to the medical community informing them of safety concerns when Aranesp® (darbepoetin alfa) was used to treat anemia in cancer patients who were not receiving chemotherapy.
In a large, randomized clinical trial, Aranesp® was compared to a placebo to reduce the need for red blood cells transfusions. Patients in the trial were not receiving chemotherapy, nor were they expected to be. Currently, Aranesp® is not FDA approved to be used with these patients.
After the sixteen-week treatment period, there was no statistically significant difference in the need for transfusions between the Aranesp group and those getting a placebo. However, there were more deaths among the Aranesp patients.
In the letter, Sean Harper, MD, who is Amgen’s corporate chief medical officer, reported:
The final analysis of the initial 16-week treatment period did not show a statistically significant effect on the primary efficacy endpoint (Hazard ratio 0.89; 95% Confidence Interval: 0.65, 1.22), with an incidence of RBC transfusions of 24% in the placebo vs. 18% in the Aranesp group, p=0.15.
In the 16-week treatment phase of the study, more deaths were reported in the Aranesp treatment group (26% (136/515)) than the placebo group (20% (94/470)). With median survival follow-up of 4.3 months the absolute number of deaths was greater in the Aranesp treatment group (216/470=46% and 250/515=49% for the placebo and the Aranesp arms, respectively, Hazard Ratio 1.25; 95% Confidence Interval: 1.04, 1.51). Follow-up of surviving patients continues. Details of this study will be presented and published in a peer-reviewed setting as soon as possible.
Amgen says that Aranesp® should only be used “in accordance with its approved product labeling for the treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitantly administered chemotherapy.” The recent study does not support its use for general fatigue or anemia in people with cancer who are not undergoing chemo.
An article about the study is in the New York Times.
Disclosure: C3 accepts unrestricted educational grants and charitable donations from Amgen along with other pharmaceutical and biotech companies. Our corporate sponsor and policy page can be found on this page.
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