Randomized Head-to-Head Trial Shows Aranesp Dosed Every Two Weeks is Comparable to Epoetin Alfa Dosed Once a Week in Breast Cancer Patients
THOUSAND OAKS, Calif.--(BUSINESS WIRE)--Dec. 11, 2004--Amgen Inc.
(Nasdaq:AMGN), the world's largest biotechnology company, today
announced that data from a head-to-head study show that 200 mcg of
Aranesp(R) (darbepoetin alfa) dosed once every two weeks has similar
efficacy to 40,000 U of Epoetin alfa dosed once every week in boosting
hemoglobin and reducing the need for blood transfusions in breast
cancer patients with chemotherapy-induced anemia. The results were
presented by one of the study's lead investigators, Lee Schwartzberg,
M.D., FACP, medical director of The West Clinic, Memphis, Tenn., at
the 27th annual San Antonio Breast Cancer Symposium (SABCS). (SABCS
"In this trial, no differences in the ability to achieve, in the
time to achieve or in the ability to maintain the target hemoglobin
range were observed between the two treatment groups," said Dr.
Schwartzberg. "These findings are important as they suggest that
Aranesp is effective in correcting anemia when administered every two
weeks, which is potentially more convenient than every week
administration for patients and caregivers."
The results were analyzed based upon the achievement and
maintenance of target hemoglobin threshold (greater than or equal to
11 g/dL) and range (11-13 g/dL, which is based on the American Society
of Hematology (ASH)/American Society of Clinical Oncology (ASCO) and
National Comprehensive Cancer Network (NCCN) guidelines for cancer and
treatment-related anemia). In the multi-center trial, 141 breast
cancer patients were randomized to receive either 200 mcg of Aranesp
dosed every two weeks (n=72) or 40,000 U of Epoetin alfa dosed once a
More than 90 percent of patients in both groups achieved
hemoglobin levels of greater than or equal to 11 g/dL (93 percent in
Aranesp group and 90 percent in Epoetin alfa group). The median time
to reach the target hemoglobin level was three weeks in the Aranesp
group and four weeks in the Epoetin alfa group. After achieving the
target hemoglobin level, 93 percent of patients in the Aranesp group
remained in the target hemoglobin range compared to 91 percent in the
Epoetin alfa group.
During the study, a lower proportion of patients treated with
Aranesp (six percent) required a blood transfusion compared with
patients treated with Epoetin alfa (16 percent). At the beginning of
the trial, mean baseline hemoglobin was 10.5 g/dL for the Aranesp
group and 10.6 g/dL for the Epoetin alfa group. At the end of
treatment, mean change in hemoglobin was 1.9 g/dL for Aranesp and 1.7
g/dL for Epoetin alfa.
Both Aranesp and Epoetin alfa had similar safety profiles in this
study. During the treatment period, 15 percent of Aranesp patients and
24 percent of Epoetin alfa patients had one or more serious adverse
events. These events were consistent with those observed in cancer
patients receiving chemotherapy and included general disorders,
administration site conditions and gastrointestinal disorders. No
thrombotic events occurred.
In July 2002, Aranesp was approved by the U.S. Food and Drug
Administration (FDA) for the treatment of chemotherapy-induced anemia
in patients with nonmyeloid malignancies. Aranesp is a recombinant
erythropoietic protein (a protein that stimulates production of
oxygen-carrying red blood cells). Amgen revolutionized anemia
treatment with the discovery of recombinant erythropoietin, Epoetin
alfa, which is currently marketed in the U.S. by Amgen as EPOGEN(R)(1)
and by Ortho Biotech Products, LP, as Procrit(R)(2). Building on this
heritage, Amgen developed Aranesp, which contains two additional
sialic acid-containing carbohydrate chains than the Epoetin alfa
molecule, resulting in more activity, with the added benefit of
less-frequent administration (for example, where Epoetin alfa is
administered three times a week, Aranesp should be administered
Aranesp 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 two-week period.
The most commonly reported side effects in Aranesp trials were
fatigue, edema, nausea, vomiting, diarrhea, fever and dyspnea.
The Aranesp dosage should be adjusted for each patient to achieve
and maintain a target hemoglobin not to exceed 12 g/dL. Doses must be
individualized to ensure that hemoglobin is maintained at an
appropriate level for each patient.
Amgen is a global biotechnology company that discovers, develops,
manufactures and markets important human therapeutics based on
advances in cellular and molecular biology.
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Aranesp prescribing information can be accessed by calling
800-772-6436 or by logging on to www.aranesp.com.
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(1) Epogen(R) is a registered trademark of Amgen, Inc.
(2) Procrit(R) is a registered trademark of Ortho Biotech
CONTACT: Amgen, Thousand Oaks
Kristen Davis, 805-447-4587 (media)
Investor Relations, 805-447-1060 (investors)
SOURCE: Amgen Inc.