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FDA Approves Darbepoetin Alfa for Anemia Associated With Chemotherapy

FDA Approves Darbepoetin Alfa for Anemia Associated With Chemotherapy

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 office visits."

Clinical Development

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."

Adverse Effects

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.

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