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Aranesp Study Shows Little Benefit for Breast Cancer Patients, Possibly Higher Rates of Death, Tumor Growth

Dec 3, 2007 | Parker Waichman LLP

Aranesp, an anemia drug, does not appear to benefit breast cancer patients.  Amgen Inc., maker of Aranesp, recently said interim results from an independent study involving breast cancer patients found Aranesp did not enhance the effect of chemotherapy prior to surgery.  The study involved over 700 patients and evaluated whether Aranesp prevented anemia and augmented the therapeutic effects of chemotherapy regimens.

Amgen also reported that participants who received Aranesp had numerically more deaths and reports of tumor growth than control group patients.  Amgen cautioned that the results-revealed amid concerns about the overuse and safety of the anemia drug class-were preliminary and conclusions should not be made until completion of the final study report.  A formal statistical analysis of survival is anticipated in early 2009.  The interim analysis shows the use of Aranesp to support neo-adjuvant chemotherapy has no significant impact on tumor response to chemotherapy at the time of surgery.  There were no deaths during the treatment period, researchers said; however, preliminary long-term, follow-up data revealed more deaths in the group receiving Aranesp, with more tumor progression events versus the control group.

The entire drug class, called erythropoiesis-stimulating agents (ESAs), has been under a microscope as debates rage over whether anemia drugs increase the risk of heart attack and stroke, and whether they may play a role in fueling the growth of cancer.

Labels for Aranesp, Epogen, and Procit had been updated to include revised dosage guidelines and information on the drugs' cardiovascular side effects. The modifications followed the Food and Drug Administration's (FDA) ordering of a black box warning-the strongest drug labeling-about cardiovascular problems and other safety. Amgen manufactures all three medications although Johnson & Johnson sells Procrit under a licensing agreement.  The drugs are part of a class of drugs known as erythropoiesis-stimulating agents (ESAs) that treat anemia in patients with kidney disease or certain cancers by boosting red blood cells.  Several studies linked the drugs to cardiovascular problems and deaths and have been tied to worsening tumors when used in cancer patients.  Soon after Epogen was introduced, some doctors attempted to use it to increase patients' hemoglobin-the part of the blood cell that carries oxygen-to levels as high as those in healthy patients (14). Two clinical trials showed the large dosage required to reach these levels could lead to heart problems and death and the black box warning cautioned doctors that the medications should be administered at the lowest dose possible to bring blood counts to the lowest level needed to avoid transfusions.  The modified black box warning now has more specific dosing information and states dosing should be individualized.  For kidney patients, the revised warning read that patients experienced greater risks for death and serious cardiovascular events when administered ESAs to target higher versus lower hemoglobin levels in two clinical studies' rather than the more generic warning that risks were seen when hemoglobin levels of greater than 12 were target.  Following the revised black box warning, Medicare announced it would not pay for Aranesp, Epogen and Procrit in patients whose hemoglobin levels were at 10 grams per deciliter.


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