US FDA panel backs Corixa's Bexxar for lymphoma
Tuesday December 17, 8:20 pm ET
BETHESDA, Md., Dec 17 (Reuters) - A U.S. advisory panel on Tuesday said the experimental cancer drug Bexxar, developed by Corixa Corp. (NasdaqNM:CRXA - News) and Britain's GlaxoSmithKline Plc (London:GSK.L - News), had benefits in treating non-Hodgkin's lymphoma.
The Food and Drug Administration committee did not vote on whether Bexxar should be approved, but did vote unanimously that the drug helps patients with the cancer of the immune system whose disease has relapsed or become resistant to chemotherapy.
"It's at least as good, if not better, than what's out there," said James Krook, a cancer specialist from Duluth, Minnesota.
The panel also voted 10-3 that Bexxar helps patients whose cancer has failed treatment with Rituxan, a different antibody-based drug.
"This is extremely good news -- it effectively legitimizes Corixa's lead drug candidate," said Paul Latta, an analyst at McAdams Wright Ragan.
Bexxar -- a combination of radioactive iodine combined with an antibody that looks for certain chemicals on cancer cells to deliver lethal radiation to the tumors -- has hit delays over the past three years as the FDA demanded more data.
"We will work diligently with the FDA and Glaxo to get this drug approved," said Michelle Burris, a spokeswoman for Corixa, noting that the agency's deadline to respond to the Bexxar marketing application is May 3, 2003.
The FDA usually follows the advice of its advisory panels, but not always.
Corixa, based in Seattle, took on the experimental drug in its December 2000 acquisition of Coulter Pharmaceuticals Inc.
"We now know that the delays at the FDA had something to do with the trial design," said Latta, referring to recent FDA staff reports highlighting the fact that Bexxar was not directly compared to traditional cancer therapy.
There are approximately 55,000 new cases and 25,000 deaths annually in the United States due to non-Hodgkin's lymphoma, a cancer that originates in the lymphatic system.
Some cases of the disease progress very slowly for years while some develop rapidly in a matter of months.
Zevalin, a similar therapy sold by San Diego-based IDEC Pharmaceuticals Corp. (NasdaqNM:IDPH - News), which also markets Rituxan, was approved by the FDA back in February.
Corixa's shares rose 27 cents, or 3.9 percent, to $7.25 on the Nasdaq exchange before trading in the stock was halted ahead of the FDA panel meeting. Year-to-date the shares have lost 52 percent of their value, compared with a 37-percent drop in the American Stock Exchange biotechnology index. |
