WEDNESDAY, Nov. 17 (HealthDay News) -- A newly approved
therapeutic prostate cancer vaccine won the support Wednesday of a
Medicare advisory committee, increasing the chances that Medicare
will pay for the drug.
Officials from Medicare, the federal insurance program for the
elderly and disabled, will consider the committee's vote when
making a final decision on payment. Such a decision is expected in
several months, the
Wall Street Journal reported. The vaccine, called Provenge
and made by the Dendreon Corp., costs $93,000 per patient and
extends survival by about four months on average, according to
results from clinical trials.
A study published in July in the
New England Journal of Medicine found that the vaccine
extended the lives of men with metastatic tumors resistant to
standard hormonal treatment, compared with no treatment. And the
therapy involved less toxicity than chemotherapy.
Provenge is a therapeutic (not preventive) vaccine made from the
patient's own white blood cells. Once removed from the patient, the
cells are treated with the drug and placed back into the patient.
These treated cells then trigger an immune response that in turn
kills cancer cells, leaving normal cells unharmed. The vaccine is
given intravenously in a three-dose schedule delivered in two-week
"The strategy of trying to harness the immune system to fight cancer has been something that people have tried to attain for many years; this is one such strategy," study lead researcher Dr. Philip Kantoff, a professor of medicine at Harvard Medical School and a medical oncologist at the Dana-Farber Cancer Institute in Boston, told HealthDay.
One expert said the therapy, while far from a cure, "looks
promising." Dr. Elizabeth Kavaler, an urologist at Lenox Hill
Hospital in New York City, said that "in this unfortunate category
of [hormone-resistant] patient, we have very little to offer.
Adding months to a man's life is better than doing nothing,
especially if the treatment involves minimal morbidity, as this
In April, the U.S. Food and Drug Administration approved
Provenge for treatment of prostate cancer that has spread to other
parts of the body and is resistant to standard hormone
For the study, Kantoff's group randomly assigned 512 men to
receive Provenge or placebo. All of patients had advanced prostate
cancer that had proven resistant to standard hormonal therapy.
On average, men receiving Provenge lived 4.1 months longer than
men receiving a placebo, the researchers found. Average survival
was 25.8 months for men in the Provenge group, compared with 21.7
months for men in the placebo group, meaning that Provenge extended
survival by 22 to 25 percent, Kantoff said.
He contends that if the vaccine were used by men with less
severe disease survival, it might be extended for even longer.
"Theoretically, if you take people with less diseases and you stimulate the immune system, you could have a more profound effect, but we don't really know that yet," he said.
Compared with other treatments, such as chemotherapy, radiation
and hormone therapy, Provenge has been touted as having fewer and
less severe side effects. In this trial, the most common side
effects were chills, fever and headache, the researchers noted.
Commenting on the high cost of Provenge, Kantoff said that "this
is a treatment given over a four-week period, as opposed to other
treatments that are given over many months, where the costs can be
high as well, if not comparable to or more expensive [than
For more information on prostate cancer, visit the
American Cancer Society.