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Dendreon CEO to CNBC: FDA Nod to Cancer Drug a 'Watershed'


Shares of Dendreon soared after Federal health advisers endorsed the company's experimental vaccine to treat advanced prostate cancer as safe and apparently effective.

The Food and Drug Administration advisers voted unanimously Thursday to say Provenge is safe. They then voted 13-4 to say there is substantial evidence that it works in treating advanced prostate cancer that no longer responds to hormone treatment.

FDA Panel Backs Provenge

During an interview on "Squawk Box" this morning, Dendreon CEO Dr. Mitchell Gold said pricing for Provenge would be comparable to other cancer treatments, but wouldn't give specific numbers. He said he is not interested in selling the company or partnering with another company to market the drug in the U.S.

Gold said he sees opportunities for many cancer patients. "Without question, this is a watershed moment for the field of cancer immunotherapies, a watershed event for patients," he told CNBC's Mike Huckman. "It should stimulate new infusions of capital to basic science research which is only going to advance the field."

The recommendation caught investors -- many of whom had sold the stock short -- by surprise, and several analysts remained skeptical that the treatment will be a success.

Dendreon sought a positive recommendation for FDA approval of what would be the first-ever therapeutic cancer vaccine, reported Huckman. The drug, Provenge, has failed to meet some testing endpoints, but also shows signs of conferring survival benefits. Another key hurdle was cleared: the panel voted unanimously--17-0--that Provenge is "reasonably safe," Huckman said.

The FDA isn't required to follow the advice of its advisory committees, but it usually does. A final FDA decision on whether to approve Provenge, also called sipuleucel-T, is expected May 15.

Neither of the two studies Dendreon submitted to the FDA in support of its application achieved their primary goal in showing Provenge delayed the progress of the disease, according to the agency.

However, the results of the first study suggested the vaccine could extend the lives of patients by 4.5 months compared to those given only a placebo.

The only other prostate cancer drug shown to prolong the lives of patients is Taxotere, also called docetaxel.

If ultimately approved, Provenge would become the first of a new class of therapies designed to stimulate a patient's own immune system against cancer, according to Dendreon.

Prostate cancer is the most common cancer in American men, other than skin cancer. The American Cancer Society estimates there will be about 220,000 new cases this year, and about 27,000 deaths.

The vaccine combines a protein found in most prostate cancers with a substance that helps specialized immune system cells recognize cancer as a threat, just as they recognize and confront germs that enter the body.

The treatment is customized for each patient. Doctors collect these cells from a patient's blood, mix them with the vaccine, and then give the concoction back to the patient.

Dendreon also is testing Provenge for less serious cases of prostate cancer.