Dendreon's prostate-cancer therapy will get accelerated FDA review

Dendreon's Provenge, intended to become the first treatment of its kind to stimulate the immune system against cancer, will get an expedited review from U.S. regulators because of its potential to save lives.

The Food and Drug Administration granted so-called priority status to the medicine, Seattle-based Dendreon said today in a statement. The agency is supposed to complete such reviews in six months, instead of the usual 10. The deadline for completing the review is May 15, the company said.

One or more panels of FDA advisers will offer opinions on Provenge in the next few months. Mark Monane, an analyst with Needham & Co. in New York, said the granting of an expedited review doesn't alter the chances that the FDA will ultimately approve the drug.

"The FDA does what the FDA wants," said Monane, who rates the Dendreon's shares "buy" and doesn't own any.

Charles Duncan, an analyst with JMP Securities in San Francisco, also said the priority status doesn't necessarily mean the company has a greater chance of winning approval for the drug.

Shares of Dendreon rose 16 cents, or 3.8 percent, to $4.39 at 1:05 p.m. New York time in Nasdaq Stock Market composite trading, after touching as high as $4.65. The stock fell 24 percent in the 12 months through Jan. 12, the previous trading day.

In a trial of 127 men who had failed on prior therapies, patients who took Provenge lived for a median time of 25.9 months, compared with 21.4 for men on a placebo, according to a Dendreon-sponsored study published in July in the Journal of Clinical Oncology. After three years of follow-up, 34 percent of patients on Provenge were alive, compared with 11 percent of those on placebo, the researcher said.

Another trial, in 98 patients, showed signs of improving survival, although the results lacked statistical significance, Dendreon said in its 2005 annual report to shareholders.

The drug's side effects in both trials were fever and chills that lasted for one to two days, according to company reports.

Provenge is from a new class of medicines called active cellular immunotherapies, which are designed to stimulate a patient's own immune system to attack prostate cancer.

Dendreon is seeking approval for Provenge to treat prostate cancer in men who have failed on hormone therapies. The disease kills more than 30,000 men in the U.S. each year, the company said.