March 06, 2007
Amgen asked to participate on FDA EPO drug panel as cloud continues to loom over class
Amgen said it has been invited to participate on a May 10 FDA panel to review the use of anemia drugs known as erythropoietin or EPO drugs in cancer patients.
Amgen in January disclosed a higher risk of death among cancer patients not undergoing chemotherapy who were treated with its blockbuster EPO drug Aranesp compared to patients given a placebo.
The upcoming panel meeting will also provide a forum for the review of Amgen’s ongoing vigilance program for Aranesp, the company’s head of research and development Roger Perlmutter said in a statement.
Aranesp, which had global sales of nearly $4 billion in 2006, is approved to treat chemotherapy-induced anemia and anemia related to kidney disease. Amgen has also been investigating the drug in a condition called anemia of cancer, or anemia in cancer not associated with chemotherapy.
The EPO class has been under a further cloud following a setback involving an experimental drug.
Last Friday, Roche temporarily suspended recruitment into a mid-stage trial of its EPO drug Cera in anemic lung cancer patients due to an imbalance of deaths across the four arms of the study.
Roche said in a published report that the deaths were driven in part by the progression of the cancer.
Meanwhile, some doctors have been curtailing the use of EPO drugs following the reports of increased deaths.
“This is very disconcerting,” said Dr. Peter Eisenberg, an oncologist at California Cancer Care in Greenbrae, CA, in a Los Angeles Times report.
Eisenberg said he still planned to prescribe the medication, especially for gravely ill patients who might not survive their cancer and would clearly benefit form the drug.
But “what do I do now with a 55-year-old patient with early breast or colorectal cancer,” he asked. “Many of them are likely to survive their disease. I’m not sure if I feel comfortable giving them something that could do them harm in that case.”