FDA Looks at Anemia Drugs, Cancer Risks

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FDA Looks at Anemia Drugs, Cancer Risks

Fri Mar 19,10:36 AM ET

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By Lisa Richwine

WASHINGTON (Reuters) - U.S. regulators are considering whether two

anemia-fighting drugs, often given to cancer patients, may in some cases

stimulate tumor growth, a question raised by studies of similar products sold in

Europe.

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The Food and Drug Administration (news - web sites) has scheduled a meeting of

outside experts for May 4 to gather input on safety issues surrounding the

medicines, Amgen Inc.'s Aranesp and Johnson & Johnson's Procrit.

 

The agency still believes the drugs are safe, and a valuable alternative to

blood transfusions, when used as directed for treating anemia in patients

receiving chemotherapy.

 

The treatments are bioengineered versions of a human protein, erythropoietin,

that stimulates production of red blood cells. Combined sales of the anemia

drugs, which are given by injection, amount to several billion dollars a year.

 

The medicines are prescribed for patients with cancer, kidney disease and other

ailments to treat anemia, a deficiency of red blood cells that causes fatigue

and other symptoms.

 

In the studies of the European products, the drugs were used differently to see

if they might help fight cancer by boosting effectiveness of chemotherapy or

radiation. Some patients received higher than normal doses, and some were not

anemic.

 

The FDA wants advice from its outside advisory committee on whether those

studies are relevant to the U.S. products, and whether more research on possible

tumor effects is needed, an agency official said.

 

One study last year found patients undergoing radiation treatment for head and

neck cancer had shorter survival times if they took Roche AG's NeoRecormon, the

company's anemia treatment sold in Europe.

 

Another trial of breast cancer patients undergoing chemotherapy was halted early

because of higher mortality among those given Johnson & Johnson's Eprex, also

sold in Europe. Survival at 12 months was 76 percent in patients given a

placebo, and 70 percent among patients treated with Eprex.

 

Some deaths resulted from progression of cancer, and others from blood clots, a

known risk, the researchers said.

 

Researchers said the findings were not definitive but did raise concerns.

 

Amgen has " fully examined all of our data, and we find no evidence of (tumor

stimulation) with Aranesp, " Amgen spokeswoman Kelly Stoddard said.

 

She said the studies of the European products were not pertinent to Aranesp

because they involved different drugs.

 

Johnson & Johnson spokesman Mark Wolfe said the company was committed to

providing patients and health-care providers " with the most complete and

up-to-date information regarding the safe use of this important class of

medications. "

 

He declined to comment further.

 

Researchers do not know why the anemia drugs might prompt tumors to grow, but

some theorize they might activate some receptors on tumors that help spur

growth.

 

 

 

 

 

 

 

 

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