FDA Panel Supports Anemia Drugs for Cancer Patients

By Steve Reinberg
HealthDay Reporter
Thursday, March 13, 2008; 11:00 AM

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THURSDAY, March 13 (HealthDay News) -- A U.S. Food and Drug Administration advisory panel voted Thursday to recommend continued use of blood-boosting drugs for cancer patients on chemotherapy, with the caveat that some cancer sufferers should steer clear of the medications.

The Oncologic Drugs Advisory Committee voted 13-1 for letting Amgen Inc. continue selling Epogen and Aranesp and Johnson & Johnson continue selling Procrit, according to the Wall Street Journal. But it also voted 11-2 to recommend against the drugs' use for cancer patients who are likely to be cured. And, in a 9-5 vote, the panel recommended the drugs not be used in patients with breast or head and neck cancer.

FDA briefing documents filed this week before the meeting showed there are eight clinical trials that now suggest these widely used medications actually speed the growth of tumors and shorten the lives of cancer victims. Known as erythropoiesis-stimulating agents (ESAs), they work by stimulating red blood cell production.

"Whereas at the time of approval safety concerns were theoretical, there is now mounting evidence of documented effects on survival, tumor progression, and thrombotic events which require a re-assessment of the net benefits of this class of drugs," FDA officials stated in the documents. "Based on data provided to FDA, there is no evidence that ESAs improve quality of life or cancer outcomes."

Reaction to the advisory recommendation was immediate.

"The panel based its decision on data that weren't statistically significant," said Dr. Samuel M. Silver, a spokesman for the American Society of Hematology. "The decisions were not based on hard science. There really wasn't any new information to change anything right now."

This issue is being driven by the fact that these are not primary therapy drugs, Silver said. "In addition, there is a feeling that they don't need the same level of evidence to look at adjunctive therapy as they do primary treatment drugs," he added.

"I wasn't surprised to see that they were trying to find a way to use it for patients who are getting chemotherapy for palliative care and not use it for patients for a curative intent, because of their concern of the tumor effects of the ESAs," Silver said.