The US Food and Drug Administration (FDA) has approved
darbepoetin alfa (Aranesp) for the treatment of chemotherapy-induced anemia in
patients with nonmyeloid malignancies. Darbepoetin alfa is a recombinant
erythropoietic protein that requires fewer injections than previous treatments
used for this indication. The agent maintains its level in the blood
approximately three times longer than epoetin alfa (Epogen, Procrit), thus
giving health-care providers the ability to treat anemia related to chemotherapy
with less-frequent dosing than the current standard of care.
"Anemia can take a tremendous toll on patients
undergoing chemotherapy, often leaving them too weak to perform routine
activities. In severe cases, anemia can force doctors to interrupt chemotherapy
regimens," said Robert E. Smith, Jr, md, president of South Carolina
Oncology Associates and a darbepoetin alfa investigator. "Aranesp not only
helps correct anemia and maintain hemoglobin levels during chemotherapy, but
also helps chemotherapy patients and their physicians overcome barriers that can
hinder the delivery of current anemia treatment, notably the need for frequent
Clinical investigations showed that patients suffering from
chemotherapy-related anemia who received darbepoetin alfa consistently reached
target hemoglobin levels and that darbepoetin alfa was generally well-tolerated.
Manufactured by Amgen, darbepoetin alfa was initially approved by the FDA in
September 2001, for the treatment of anemia associated with chronic renal
failure in patients who may or may not be on dialysis.
"Aranesp is an important development that will make it
easier for oncologists to treat their chemotherapy patients’ anemia,"
said Amgen chairman and chief executive officer Kevin Sharer. "Joining the
once-per-chemotherapy-cycle dosed pegfilgrastim (Neulasta), Aranesp’s
simplified dosing regimen represents Amgen’s next generation of powerful
supportive care treatments for patients receiving chemotherapy."
Darbepoetin alfa is contraindicated in patients with
uncontrolled hypertension. Erythropoietic therapies may increase the risk of
thrombotic and other serious events; dose reductions are recommended if the
hemoglobin increase exceeds 1.0 g/dL in any 2-week period.
The most commonly reported side effects in trials of darbepoetin alfa have
been fatigue, edema, nausea, vomiting, diarrhea, fever, and dyspnea. No
important differences with regard to side effects were observed between
darbepoetin alfa and epoetin alfa.