AMGEN: ANEMIA DRUG SHOULD NOT BE USED FOR OFF-LABEL CANCER TREATMENT

Amgen's anemia drug Aranesp should not be used to treat fatigue or to reduce the need for red blood cell transfusions in cancer patients because it is ineffective and potentially dangerous for these uses, the company said.

Amgen alerted the oncology medical community in a Jan. 26 letter that it should not prescribe Aranesp (darbepoetin alfa) for off-label use based on the results of the company's randomized, placebo-controlled study of the drug. Not only was the drug no more effective than a placebo in reducing the number of transfusions needed or reducing fatigue, but there were also more deaths associated with Aranesp's use than with the placebo, the company said. The FDA has only approved the drug for the treatment of patients with anemia.

Aranesp is an erythropoietic protein that works in a similar way to the body's natural erythropoietin, a glycoprotein produced by the kidneys that circulates through the bloodstream to bone marrow, where it stimulates red blood cell production. Worldwide sales of Aranesp were $3.3 billion in 2005.

The letter is available at www.fda.gov/medwatch/safety/2007/Aranesp_DHCP_012707.htm (http://www.fda.gov/medwatch/safety/2007/Aranesp_DHCP_012707.htm).