• 3/14/2008
  • Gathersburg, MD
  • Lisa Richwine and Kim Dixon
  • www.reuters.com

The widespread use of anemia drugs sold by Amgen Inc and Johnson & Johnson should be sharply restricted for cancer patients amid serious safety concerns, a U.S. advisory panel said on Thursday.

The Food and Drug Administration panel recommended against giving the medicines to patients with potentially curable cancers who are undergoing treatment, or to patients with advanced breast cancer or head and neck cancer.

“How long do patients have to continue to be exposed to a drug that we are not sure is safe?” said Dr. Judith Kramer of Duke University and a panel member.

The FDA typically takes the advice of its expert panels.

The recommendations come after eight studies found evidence of tumor growth or shorter survival for some patients given high doses of the drugs, which include Amgen’s top-selling product Aranesp and J&J’s Procrit.

Tens of thousands of cancer patients take the drugs for anemia caused by chemotherapy. Anemia, or low levels of red blood cells, causes fatigue and weakness.

The drugs, known as erythropoiesis-stimulating agents (ESAs), are genetically engineered forms of a protein that boosts production of red blood cells. The injectable medicines also are sold for patients with kidney disease.

The panel rejected, in a 13-1 vote, a more extreme option of recommending a complete withdrawal of all approved uses for cancer patients.

The panel is saying “if you want to cure a patient with chemo, don’t kill them with an ESA,” King said.

Amgen issued a brief statement saying it would work with the FDA as the agency considered changes to the drug labels.

The company said it “takes very seriously the safety signals seen in recent trials where ESAs were used outside of” the currently approved uses.

Ortho Biotech, the Johnson & Johnson unit that sells Procrit, said it was “concerned” by the panel’s decision and believed “fully informed patients and their physicians should have the choice to use this important medication.”

The committee ruled 11-2 with one abstention to urge that the drug labels say they are not approved for patients with curable cancers, and 9-5 that they advise doctors against use for metastatic breast cancer or head and neck cancer.

Panelists also voted 8-5 to recommend that patients should sign consent forms before being treated with the medicines.

“We got a clear message that they felt the drugs should still be available, at least in certain oncology patients,” said John Jenkins, director of the FDA’s office of new drugs. “But we also got a clear sense that they are concerned about the risks.”

There is little data on the drugs’ risks when given according to current guidelines, FDA officials and panel members said. “We need more data” was a common refrain throughout the meeting.

Earlier, Amgen and J&J officials said the overall evidence from 59 studies showed they offered benefits for chemotherapy patients that outweighed the risks when used appropriately. Studies show their use reduces the need for blood transfusions to treat anemia.

A year ago, the companies added strong “black box” warnings to the medicines and sales dropped sharply. New information was added to the warnings last week.