Provenge provides a new
treatment option for men with advanced prostate cancer,
who currently have limited effective therapies available,"
Karen Midthun, acting head of the Food and Drug
Administration's biologics center, said in a statement.
Unlike traditional vaccines
that prevent a disease, Provenge treats prostate cancer
by stimulating the body's own immune system to attack
malignant cells. It is produced by taking cells from a
patient's tumor and incorporating them into a vaccine
that is injected back into the patient.
The field has been littered
with failures. Dendreon is the first company to show a
cancer vaccine can extend patient survival. In a late-stage
study of 512 patients, men given Provenge lived an
average of 4.1 months longer than those who got a
Common side effects were chills,
fever and headache that lasted up to two days following
infusion. This is seen as an advantage over the
debilitating side effects typical of chemotherapy.
Most reactions were mild or
moderate but one-quarter of patients reported a serious
problem, the FDA said. Problems such as strokes were
seen in 3.5 percent of Provenge patients compared with
2.6 percent in the placebo group.
Dendreon said Provenge would
cost a total of $93,000 for the full treatment of three
Prostate cancer is the second
most common cancer among U.S. men behind skin cancer and
usually occurs in older men.
The FDA approved Provenge for
hormone-resistant prostate cancer that has spread in the
body but is causing no or minimal symptoms.
Dr. Len Lichtenfeld, deputy
chief medical officer at the American Cancer Society,
said Provenge would give a boost to future efforts to
develop treatment vaccines for cancer.
"This is exciting because it
does represent a proof of concept. (Provenge) does seem
to prolong life in a very specific group of men," he
Other companies are exploring
the field. GlaxoSmithKline (GSK.L)
is studying a lung cancer vaccine while Bristol-Myers
is testing a melanoma vaccine.
Danish biotech Bavarian Nordic
is about to start late-stage testing of a rival prostate
cancer vaccine called Prostvac that does not need to be
tailored to the individual patient.