FDA Looks at Anemia Drugs, Cancer Risks
- FDA Looks at Anemia Drugs, Cancer Risks
Fri Mar 19,10:36 AM ET
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.
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 &
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
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
Amgen has "fully examined all of our data, and we find no evidence of
(tumor stimulation) with Aranesp," Amgen spokeswoman Kelly Stoddard
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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