July 23, 2002
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New drug for relieves anemia for chemotherapy patients

THOUSAND OAKS, Calif. -- July 23, 2002 -- The FDA approved today a drug that helps cancer patients overcome fatigue, one of the most common side effects of chemotherapy, by stimulating the production of red blood cells.

The drug, marketed under the name Aranesp® by biotech drugmaker Amgen, is an engineered protein that stimulates red blood cell for up to three times longer than currently available treatments.

Dr. Robert Smith, a clinical oncologist at the South Carolina Oncology Associates, an and investigator for the Aranesp clinical trials, says the drug can help patients complete their chemotherapy regimens.

"Anemia can take a tremendous toll on patients undergoing chemotherapy often leaving them unable to perform routine activities," Smith said in a press release. "Aranesp not only helps correct anemia and maintain hemoglobin levels during chemotherapy, but also helps chemotherapy patients overcome barriers that can hinder the delivery of current anemia treatment, notably, the need for frequent office visits."

The drug represents a second-generation, synthetic erythropoietin (erithro·poi·e·tin), which was the first drug developed through bioengineering. Marketed under the name Epogen®, it was introduced by Amgen in 1984 for the treatment of low red blood cell production in patients with kidney failure.

Last fall the FDA approved Aranesp for kidney failure, and today's FDA approval makes it available to certain cancer patients undergoing chemotherapy. Because Aranesp is given in single injections less frequently, patients require fewer office visits and fewer needle sticks as compared to Amgen's first anemia drug,

The approval for chemotherapy patients was based on clinical studies that showed the drug consistently boosted red blood cell production to targeted levels and was well tolerated by patients. It is not appropriate for patients with high blood pressure that cannot be controlled.

This year 1.2 million cancer patients in the United States will undergo chemotherapy and 800,000 of them will become anemic in the process because many chemotherapy drugs work by killing fast dividing cells, which includes red and white blood cells as well as cancer cells.