3/12/08 Source: FDA MedWatch
Amgen and FDA notified healthcare professionals of changes to the Boxed Warnings/WARNINGS: Increased Mortality and/or Tumor Progression section of the Aranesp and EPOGEN/PROCRIT labeling to update information describing the results of two additional studies showing increased mortality and more rapid tumor progression in patients with cancer receiving ESAs. Based on the results of these studies, the prescribing information has been revised as follows: ESAs shortened overall survival and/or time to tumor progression in clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers when dosed to target a hemoglobin of ¡Ý 12 g/dL.
Read the complete 2008 MedWatch Safety Summary including a link to the manufacturer's Dear Healthcare Professional Letter regarding this issue at:
Please see the "Leading Edge" discussion from Lancet Oncology below. February 2, 2008
January 2008 FDA Consumer Update: Anemia Drugs' RISKS
"All eight studies together show more rapid tumor growth or shortened survival for patients with breast, non-small cell lung, head and neck, lymphoid or cervical cancers that received ESAs, compared to those patients who did not receive the treatment". Complete release below.
July 2006 UPDATE AHRQ "Study Finds NO Clinically Significant Difference in Effectiveness of Drugs for Managing Amemia in Patients Undergoing Cancer Treatment"
(see details below because there is NO survival advantage and instead of 50% needing transfusion, the drugs reduce it to 30%)
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Darbepoetin alfa administered every 2 weeks alleviates anemia in cancer patients receiving chemotherapy.
Glaspy JA, Tchekmedyian NS.
UCLA School of Medicine, UCLA Oncology Center, Los Angeles, California, USA. firstname.lastname@example.org
The objectives of this study were to assess the safety and efficacy of darbepoetin alfa (Aranesp) administered every 2 weeks in anemic patients with solid tumors receiving chemotherapy. This was an open-label, randomized, active-controlled, multicenter dose-finding study evaluating a range of every-2-week darbepoetin alfa doses.
The active control arm received epoetin alfa (Epogen, Procrit) at 40,000 U weekly with a dose increase to 60,000 U weekly for subjects with an inadequate response.
The lowest clinically effective doses of darbepoetin alfa in this study were 3.0 and 5.0 microg/kg every 2 weeks, with no additional benefit observed at higher doses.
The percentage of patients who achieved a hematopoietic response in the 3.0- and 5.0-microg/kg groups was 66% (95% confidence interval [CI] = 46%-86%) and 84% (95% CI = 67%-100%), respectively, compared with 63% (95% CI = 46%-81%) in the epoetin alfa group.
Darbepoetin alfa administered at a dose of 3.0 microg/kg every 2 weeks is safe and effective for treating anemia in patients with solid tumors on chemotherapy, and is comparable to epoetin alfa.
A dose increase to 5.0 microg/kg of darbepoetin alfa administered every 2 weeks may be appropriate in patients with an inadequate initial response.
Oncology (Huntingt). 2002 Oct;16(10 Suppl 11):23-9.
Reuters Health, NYTimes,
J Clin Oncol, 10/98
Press Release from
Agency for Healthcare Review and Quality
Our source: gooznews.com, February 2007
Current Med Res & Opinion, 1/04
FDA on Aranesp Higher Mortality Rate
Darbepoetin Worsens 5-Year Survival in Head and Neck Cancer
New York Times, May 9, 2007
Ann Fonfa's remarks on FDA Hearing - Anemia Drugs
Full Text of Lilla Romeo's remarks to FDA Oncologic Drugs Advisory Committee
FDA Consumer Update, January 2008
LINK to article about
latest FDA warnings, 1/03/08
Lancet Oncology, February 2, 2008
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