Cancer-drug review stepped up

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

The Food and Drug Administration (FDA) granted so-called priority status to the medicine, Seattle-based Dendreon said Tuesday in a statement.

The agency is supposed to complete such reviews within six months, instead of the usual 10. The deadline for completing the work on Provenge 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. Monane, in a research report Tuesday, wrote that the drug has a 50 percent chance of winning clearance in 2007.

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

Dendreon, the only local biotech with a potential blockbuster near FDA approval, is seeking approval for Provenge to treat prostate cancer in men in whom hormone therapies failed. The American Cancer Society estimates that 27,350 men died from the disease in the U.S. in 2006, and 234,000 new cases were diagnosed.

David Miller, president of Biotech Stock Research, a Seattle-based newsletter, said the expedited review doesn't improve Provenge's odds of approval. If the FDA does approve it by May 15, Dendreon may market the drug during two key medical meetings, of the American Urological Association in late May and the American Society of Clinical Oncology in early June.

Miller said that while "there is no doubt Provenge works," FDA advisers may ask for more proof. "It all comes down to whether the advisory panel is more interested in process, and statistics, than patients."

The news pushed Dendreon stock up 20 cents, or 4.7 percent, to $4.43 Tuesday.

In a trial of 127 men who had failed on previous 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.

Follow-up results

After three years of follow-up, 34 percent of patients on Provenge were alive, compared with 11 percent of those on the placebo, the researchers 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.

The company, which has no marketed drugs, has much at stake in the Provenge application. It was founded in 1992 to develop a new class of medicines called active cellular immunotherapies, which are designed to stimulate a patient's immune system to attack prostate cancer.

Dendreon accumulated a deficit of $370.9 million from its founding through the third quarter of 2006, according to the company's annual report filed with the U.S. Securities and Exchange Commission.

Dendreon's only other product in clinical development is an immune-stimulating drug against breast cancer, according to the company Web site.

Commercial potential

Analyst reports show a range of estimates for Provenge's commercial potential. Monane, of Needham & Co., estimated that if the drug is approved in 2007, it could reach $1 billion a year in peak sales by 2011.

Joel Sendek, an analyst with Lazard Capital Markets, wrote in a report Tuesday that the FDA may wait for more study results and approve the drug in 2009. Under that scenario, he said Provenge may reach sales of $231 million in 2011.

The company is studying the drug in prostate-cancer patients with earlier stages of disease, which could make the medicine available to about 1.5 million patients on standard hormone therapies, according to Monane.

Seattle Times staff contributed to this report.