FDA sets panel on anemia drugs in cancer: Amgen

Last Updated: 2007-03-01 11:00:37 -0400 (Reuters Health)

LOS ANGELES (Reuters) - Amgen Inc., the world's largest biotechnology company, said on Wednesday it would participate in a May 10 U.S. Food and Drug Administration panel reviewing the use of anemia drugs in cancer patients.

The company announced in January trial results showing a higher risk of death for advanced cancer patients not undergoing chemotherapy or radiation who were treated with its anemia drug Aranesp compared to patients given a placebo.

The upcoming panel meeting will also provide a forum for review of Amgen's ongoing vigilance program for Aranesp, Roger Perlmutter, the company's head of research and development, said in a statement.

He said the company planned to announce in May top-line results from a trial involving Aranesp in patients with previously untreated small cell lung cancer.

The company said it was discussing with the FDA an update of patient safety information on labels for drugs that stimulate production of red blood cells that will take the form of a boxed warning and will apply to both nephrology and oncology indications.

Aranesp is approved to treat chemotherapy-induced anemia and anemia related to kidney disease. Amgen has been investigating the drug in a condition called anemia of cancer, or anemia in cancer not associated with chemotherapy.