'Cancer vaccine' approved by FDA

A therapy that prompts the immune system to kill prostate cancer has become not only a new way to treat advanced disease but also is the first "cancer vaccine" to pass federal muster, drug regulators announced Thursday.

Known as Provenge, the treatment was widely tested on Long Island in clinical trials required for its U.S. Food and Drug Administration approval.

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The treatment is for men with advanced cancers. It's called a vaccine because the therapy boosts the immune system to stop tumor proliferation. Provenge doesn't prevent cancer the way a flu shot thwarts infection, it cues specific warrior cells in the immune system to zero in on tumor cells and destroy them.

"What's exciting about this concept is that it can also be applied to other forms of cancer," said Dr. E. Roy Berger, who led research of the therapy at North Shore Hematology and Oncology in East Setauket.

[CORRECTION: The Long Island study site for a new prostate cancer treatment was North Shore Hematology and Oncology in East Setauket, not John T. Mather Hospital in Port Jefferson as stated in the story.]

He suggested it could also have relevance for breast, bladder and kidney cancers.

Until Thursday, men with advanced prostate cancer - disease that spreads beyond the gland - had very limited options. Other approved treatments include a drug so toxic, Berger said, some of his elderly patients say they'd rather die than take it.

Long Island has a strong stake in the new therapy's approval because a "substantial number" of the 512 patients who participated in the latest clinical trial came from here. "I was the highest enrolling doctor on the last two trials," Berger said, declining to provide the actual patient number.

Patient support groups welcomed the federal decision. "I was delighted when I saw the news," said Win Boerckel, director of social services at Cancer Care of Long Island in Woodbury, which provides counseling, financial and support services for patients.

Despite its promise as a new form of cancer treatment, Provenge's path to approval was stormy. Patients' hopes were dashed three years ago when the FDA rejected it, calling for more research. The rejection triggered a groundswell of anger from patients and threats of a congressional probe.

Provenge increases survival by 4.1 months compared with traditional therapies, said Dr. Nina Bhardwaj, director of the tumor vaccine program at NYU's Langone Medical Center in Manhattan. The median survival for Provenge patients is 25.8 months compared with 21.7 months for those on other forms of treatment. Bhardwaj said the difference bolsters "approaches that use cell-based vaccines to treat cancer."

Yet Provenge isn't cheap. The treatment, developed by Dendreon Corp., in Seattle, costs about $93,000.

Every dose, Berger said, is custom-made for each patient, making it one of the few true forms of personalized medicine. Immune-system cells are extracted from the patient, dispatched to a laboratory in New Jersey where they're "loaded" with an enzyme called prostatic acid phosphatase. The loaded cells are then reinfused into the patient.

Once flowing in the blood, loaded cells recruit the immune system's T cells - orchestrators of the body's immune response - into killing cancer.

Approval was seen as inevitable this time around, Berger said, because there was "too much pressure from support groups, patients and physicians not to approve it."

Provenge primer

THE BREAKTHROUGH: A first-of-a-kind cancer treatment that uses the body's immune system to fight advanced prostate cancer.

HOW IT WORKS: Each regimen of Provenge must be tailored to the immune system of the patient. Doctors collect special blood cells from each patient that help the immune system recognize cancer as a threat. The cells are mixed with a protein found on most prostate cells and another substance to energize the immune system. The resulting "vaccine" is given back to the patient as three infusions two weeks apart.

SIDE EFFECTS: Relatively mild, such as chills, fatigue, fever and headache.

COST: $93,000 per patient.

WHO GETS IT: Initially, Dendreon Corp., the developer of the treatment, will identify Provenge patients through the 50 medical centers that helped test the drug. But researchers have been told the company will only be able to provide vaccines for a few patients at each site per month.

[CORRECTION: The Long Island study site for a new prostate cancer treatment was North Shore Hematology and Oncology in East Setauket, not John T. Mather Hospital in Port Jefferson as stated in the story.]