FDA staff to ask panel about anemia drug limits

Typography

"There is now mounting evidence of documented effects on survival, tumor progression, and thrombotic events which require a reassessment of the net benefits of this class of drugs," Food and Drug Administration staff wrote in a summary prepared for the advisory panel.

WASHINGTON (Reuters) - U.S. health officials will ask an advisory panel whether they should remove the approval of Amgen Inc <AMGN.O> and Johnson & Johnson <JNJ.N> anemia drugs for cancer chemotherapy patients or take other actions to minimize risks, documents released on Tuesday said.

"There is now mounting evidence of documented effects on survival, tumor progression, and thrombotic events which require a reassessment of the net benefits of this class of drugs," Food and Drug Administration staff wrote in a summary prepared for the advisory panel.

The panel of outside experts meets Thursday to review the risks of the drugs, which include Amgen's Aranesp and Johnson & Johnson's Procrit, when given to cancer patients.

(Reporting by Lisa Richwine, editing by Gerald E. McCormick)

!ADVERTISEMENT!