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Originally published April 29, 2010 at 10:41 AM | Page modified May 5, 2010 at 12:03 PM

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FDA approves country's first cancer-treatment vaccine

An 18-year roller-coaster ride for Seattle biotech Dendreon ended on a high point Thursday, with federal approval of the country's first cancer-treatment vaccine.

Seattle Times science reporter

Information

Provenge call center for doctors and patients:

1-877-336-3736

Dendreon website:

www.dendreon.com

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After more than 15 years of research and toil, you might expect the folks at Dendreon to relax a little after getting the green light for the country's first cancer-treatment vaccine.

But in some ways, the hard work is just beginning for the Seattle biotech.

"We're going to have to get busy pretty quickly," said company CEO Dr. Mitchell Gold.

Demand is already high for Provenge, the immune-boosting prostate-cancer drug approved Thursday by the U.S. Food and Drug Administration.

Dendreon is ramping up production as quickly as possible, Gold said. But until the company can get manufacturing plants in New Jersey, Georgia and California running at full capacity, many men who could potentially benefit from the treatment won't be able to get it.

Over the next 12 months, the company estimates it will be able to produce enough Provenge to treat about 2,000 men. As many as 100,000 Americans a year develop the advanced form of prostate cancer the vaccine was approved to treat — though not all of them would be good candidates for Provenge.

Initially, treatment will be offered through 50 centers across the country where clinical trials on the drug were conducted. They include Virginia Mason Medical Center and Seattle Cancer Care Alliance in Seattle.

"This opens up a whole new avenue of therapy for patients with a pervasive disease," said Dr. John Corman, a prostate-cancer specialist at Virginia Mason who has been involved in Provenge studies for eight years. "It really is a potentially new era in treating cancer in general and prostate cancer specifically."

Patients and their families have been asking about the drug and tracking its roller-coaster ride through the regulatory process for years, Corman said. "I must talk about this with 10 patients a day."

While traditional vaccines prime the immune system to prevent infection, Provenge works to rev up the immune systems of men who already have cancer.

Immune-system cells are isolated from the patients' blood via a dialysis-like procedure, then incubated with proteins from prostate-cancer cells. The process "trains" the immune cells to attack the cancer once they are infused back into the patient. A course of treatment consists of three infusions, spread over a month.

Each vaccine is personally tailored for each patient, which is one of the reasons the company won't reach full manufacturing speed until the middle of next year, said Hans Bishop, Dendreon chief operating officer.

In studies of men with prostate cancer that had stopped responding to hormone treatment and spread to other parts of their bodies, Provenge boosted median survival time by about 4 months — from 22 months in the placebo group to 26 months among men who got the drug. About a third of men who got the vaccine were alive after three years, compared with fewer than a quarter of those who got the placebo.

Provenge's side effects were mild, compared to the chemotherapy that has been the only treatment option for men with this form of the disease.

"It's an important advance because of how tough prostate cancer has been to treat," said oncologist Dr. Tom Beer of Oregon Health & Science University's Knight Cancer Institute.

But patients shouldn't expect too much, cautioned Dr. Mario Eisenberger, professor of oncology at Johns Hopkins University. "I'm very happy we have something new, but this is undoubtedly not a magic bullet."

There's still no way to tell which patients will benefit most from Provenge, he said. And while Provenge improved overall survival, it didn't appear to shrink tumors or lower men's PSA scores — an indication of cancer growth — the way chemotherapy does. That means doctors have no benchmarks they can use to tell whether Provenge is working in any individual patient, Eisenberger said.

In a conference call with analysts and investors Thursday, Dendreon announced that a course of Provenge will cost $93,000.

The sticker shock won't hit most men directly. Medicare will cover the treatment for men 65 and older. Most insurance plans are expected to follow suit.

Dendreon will offer financial assistance for those who can't afford the drug.

Though Provenge was approved specifically for advanced prostate cancer, it may prove even more powerful in men with earlier stages of the disease whose immune systems haven't been hammered by radiation and chemotherapy, said Corman, who is involved in studies to answer that question.

Doctors are allowed to prescribe drugs "off-label," and Corman said he's already getting requests from recently diagnosed men.

It's not clear yet whether insurance companies will restrict coverage to only patients with advanced cancer.

With potential revenues of more than $1 billion year, and several other cancer vaccines in the pipeline, Dendreon is now the "anchor tenant" that Seattle's biotech community has lacked, said David Miller, president of Biotech Stock Research in Seattle.

"This is huge for Seattle," he said.

Gold said the company intends to stick around.

"Our intention here is to create a long-lasting, durable business and create products that will help people with cancer live longer and have better lives."

Sandi Doughton: 206-464-2491 or sdoughton@seattletimes.com

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