FDA panel recommends restricting anemia drug to chemo patients

WASHINGTON A Food and Drug Administration panel has recommended that such anemia drugs as Aranesp and Epogen manufactured by Amgen and Procrit by Johnson & Johnson should be restricted to chemotherapy patients and limited to those with uncurable forms of cancer.

The cancer experts overwhelmingly voted to keep the drugs on the market for chemotherapy patients, but said use should be limited to those with uncurable forms of cancer. The experts also voted 9-5 to withdraw the drug's use in patients with breast or head-and-neck cancers, such as those affecting the sinuses, throat and lymph nodes. Another positive for the companies was when the panel asked whether it recommended the drugs for anemia caused by cancer treatment, the FDA committee voted 13-1 in favor.

In a statement after the meeting, Amgen said it "takes very seriously the safety signals seen in recent trials where [the drugs] were used outside of the labeled indication. The role of the [panel] is to advise the FDA. We are committed to working with the FDA to consider the input from the committee and to implement future label changes."

Aranesp sales totaled $3.6 billion in 2007, with more than $2 billion related to cancer. J&J said at least half of Procrit's $1.7 billion in U.S. sales last year was related to cancer treatment.