FDA Panel to Review Idec Drug
Idec Pharmaceuticals Corp. said Monday that a government advisory panel will review its radioactive treatment for non-Hodgkin’s lymphoma on Sept. 11.
The review is important for Idec, as the Food and Drug Administration typically follows the recommendation of its committees. If approved by the FDA, the drug, known as Zevalin, would be the first of its kind. It also would be the first drug that Idec would manufacture and market on its own.
Zevalin is an antibody that specifically targets lymphoma tumors and doses them with radiation. In clinical trials, the medication had a positive effect in 74% of patients who failed to respond to other cancer treatments.
The timing of the FDA review appears to give San Diego-based Idec an edge over rival Corixa Corp., which is developing a similar drug for non-Hodgkin’s lymphoma, a type of blood cancer.
Analysts said if the FDA panel gives Zevalin a favorable review the drug could be approved this year. Sales forecasts range from $50 million to $112 million. Carol Werther, an analyst with Adams Harkness & Hill of Boston, said Zevalin could become a $300-million-a-year drug.
Analysts said sales are limited in part by the nature of the drug. Because it is radioactive, it can be used only at approved facilities.
Zevalin initially would be used for patients who failed other lymphoma treatments, such as chemotherapy or Idec’s Rituxan, the first engineered antibody approved to treat cancer. Rituxan, which Idec markets in partnership with Genentech Inc., is expected to have sales of $1 billion by next year.
Rituxan has few side effects and has positive results in nearly half of patients using it. But, within an average of 10 to 12 months, the disease advances.
Idec filed for approval of Zevalin last fall. In May, the FDA asked for more information about the drug, which the company provided in June. The FDA also has asked Corixa for more information about its drug, called Bexxar. The company has not yet answered the FDA.
Idec shares rose $2.06 to $55.04 on Nasdaq. Shares of Corixa, based in Seattle, fell $1.60 to $13.20.
Separately, Mylan Laboratories said it received FDA approval to sell a generic version of the breast cancer drug, Taxol.
