Panel Backs Further Anemia-Drug Tests

A Food and Drug Administration panel agreed Tuesday that clinical trials were needed to determine how anti-anemia drugs sold by Amgen Inc. and Johnson & Johnson affect cancer patients.

The FDA convened the panel for advice on how to conduct human tests of the blockbuster drugs. Safety questions about tumor growth and blood clotting arose from several studies in Europe that involved anemia drugs not sold in the U.S. but which are similar to Procrit, which is made by Amgen and sold by Johnson & Johnson.

All the drugs are synthetic versions of erythropoietin, a natural hormone that stimulates production of red blood cells.

Representatives of the companies said they had no evidence that their drugs spurred tumor growth. However, they said they had agreed to perform additional studies and that some trials already were underway.

The drugs’ labels already carry information about the possibility of blood-clot formation.

“Not only is it reasonable but it is necessary to do additional trials,” said panel chair Bruce D. Cheson, head of hematology at the Lombardi Cancer Center at Georgetown University.

Procrit and a version of it sold abroad had sales of $3.9 billion in 2003. The drug is heavily advertised to relieve anemia and fatigue in cancer patients who have had chemotherapy. It has been sold since 1993.

Aranesp, a long-acting version of Procrit, is made and sold by Thousand Oaks-based Amgen. It reached the market in 2001. Amgen’s anemia drugs also had sales of $3.9 billion last year.

The FDA said the studies previously conducted by Amgen and J&J; weren’t designed to show how the drugs affected cancer patient survival.

Amgen shares closed down 24 cents to $57.70 on Nasdaq and J&J; shares fell 13 cents to $54.80 on the New York Stock Exchange.