Amgen Announces FDA Approval of Every-Three-Week Dosing of Aranesp(R) for Chemotherapy-Induced Anemia

Strategic Insights -

Amgen, the world's largest biotechnology company, has announced that the U.S. Food and Drug Administration (FDA) has approved every-three-week dosing of Aranesp(R) (darbepoetin alfa) for the treatment of chemotherapy-induced anemia in patients with non-myeloid malignancies. Aranesp is the only erythropoiesis-stimulating agent approved by the FDA for every-three-week administration. This approval is an important milestone, allowing anemia treatment to be synchronized with both weekly and every-three-week chemotherapy, which are the most commonly used treatment regimens. This offers improved convenience for patients and less injection-related burden for patients and healthcare professionals compared to weekly anemia treatment.

Key Takeaways:

  • The FDA has approved every-three-week dosing of Aranesp(R) (darbepoetin alfa) for the treatment of chemotherapy-induced anemia in patients with non-myeloid malignancies.
  • Aranesp is the only erythropoiesis-stimulating agent approved by the FDA for every-three-week administration.
  • The approval of an extended dosing protocol for Aranesp is an important milestone, allowing anemia treatment to be synchronized with both weekly and every-three-week chemotherapy.
  • This offers improved convenience for patients and less injection-related burden for patients and healthcare professionals compared to weekly anemia treatment.
  • In clinical studies, Aranesp has proven effective in reducing the incidence of red blood cell transfusions and boosting and maintaining target hemoglobin levels when administered every three weeks.
  • Patients with chemotherapy-induced anemia were randomized to receive 500 mcg of Aranesp every three weeks (n=353) or 2.25 mcg/kg (n=352) administered weekly for up to 15 weeks.
  • The update to the Aranesp label now includes a recommended starting dose of 500 mcg once every three weeks in addition to the recommended starting dose of 2.25 mcg/kg once weekly.
  • More than 70 percent of patients in the every-three-week group required dose reductions, resulting in an average weekly dose of 125 mcg for the patients in this group.
  • The approval of every-three-week dosing of Aranesp marks a significant milestone in the treatment of chemotherapy-induced anemia, offering improved convenience and less burden for patients and healthcare professionals.
  • About 800,000 (67 percent) of chemotherapy patients will become anemic in the United States this year.
  • Approximately half of patients with a hemoglobin level less than the recommended target level of 11 to 12 g/dL in the National Comprehensive Cancer Network(R) (NCCN) guidelines for "Cancer and Treatment-Related Anemia" are never treated with erythropoietic therapy.

Statistics:

  • 1.3 million cancer patients will undergo chemotherapy in the United States this year.
  • 800,000 (67 percent) of chemotherapy patients will become anemic.
  • More than 70 percent of patients in the every-three-week group required dose reductions.
  • The average weekly dose of 125 mcg for patients in the every-three-week group.
  • Approximately 800,000 anemia cases in chemotherapy patients are under-treated.
  • The update to the Aranesp label now includes a recommended starting dose of 500 mcg once every three weeks.

Sources:

  • Amgen news release (2006)
  • U.S. Food and Drug Administration (FDA) approval letter
  • National Comprehensive Cancer Network (NCCN) guidelines for "Cancer and Treatment-Related Anemia" (2006)
  • Amgen press release (2001)
  • Aranesp prescribing information