Split decision for Amgen

An FDA panel voted 13-1 in favor of allowing the company to keep marketing its lucrative anemia drug to cancer patients, but with additional restrictions. It should not be used by patients with either breast cancer or head and neck cancer or by patients with early-stage cancer who are undergoing chemotherapy after removal of a tumor. If approved by the commission, those restrictions will surely cut into sales of Amgen’s Aranesp (as well as Procrit by Johnson & Johnson), but at least the companies avoided an outright ban. The panel met because eight clinical trials have suggested that the drugs might make cancer worse for some patients or even shorten their lives. But the trials involved high doses of the drugs - not those typically used by cancer doctors. Amgen stock was up almost 5 percent for the day. (NYT, WSJ)