FDA Approves Darbepoetin Alfa for Anemia Associated With Chemotherapy

September 1, 2002

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.

The US Food and Drug Administration (FDA) has approveddarbepoetin alfa (Aranesp) for the treatment of chemotherapy-induced anemia inpatients with nonmyeloid malignancies. Darbepoetin alfa is a recombinanterythropoietic protein that requires fewer injections than previous treatmentsused for this indication. The agent maintains its level in the bloodapproximately three times longer than epoetin alfa (Epogen, Procrit), thusgiving health-care providers the ability to treat anemia related to chemotherapywith less-frequent dosing than the current standard of care.

"Anemia can take a tremendous toll on patientsundergoing chemotherapy, often leaving them too weak to perform routineactivities. In severe cases, anemia can force doctors to interrupt chemotherapyregimens," said Robert E. Smith, Jr, md, president of South CarolinaOncology Associates and a darbepoetin alfa investigator. "Aranesp not onlyhelps correct anemia and maintain hemoglobin levels during chemotherapy, butalso helps chemotherapy patients and their physicians overcome barriers that canhinder the delivery of current anemia treatment, notably the need for frequentoffice visits."

Clinical Development

Clinical investigations showed that patients suffering fromchemotherapy-related anemia who received darbepoetin alfa consistently reachedtarget hemoglobin levels and that darbepoetin alfa was generally well-tolerated.Manufactured by Amgen, darbepoetin alfa was initially approved by the FDA inSeptember 2001, for the treatment of anemia associated with chronic renalfailure in patients who may or may not be on dialysis.

"Aranesp is an important development that will make iteasier for oncologists to treat their chemotherapy patients’ anemia,"said Amgen chairman and chief executive officer Kevin Sharer. "Joining theonce-per-chemotherapy-cycle dosed pegfilgrastim (Neulasta), Aranesp’ssimplified dosing regimen represents Amgen’s next generation of powerfulsupportive care treatments for patients receiving chemotherapy."

Adverse Effects

Darbepoetin alfa is contraindicated in patients withuncontrolled hypertension. Erythropoietic therapies may increase the risk ofthrombotic and other serious events; dose reductions are recommended if thehemoglobin increase exceeds 1.0 g/dL in any 2-week period.

The most commonly reported side effects in trials of darbepoetin alfa havebeen fatigue, edema, nausea, vomiting, diarrhea, fever, and dyspnea. Noimportant differences with regard to side effects were observed betweendarbepoetin alfa and epoetin alfa.