FDA Approves Dendreon's Prostate Cancer Vaccine Provenge
Dow Jones Newswires April 29, 2010 By Jennifer Corbett Dooren
WASHINGTON (Dow Jones)--The Food and Drug Administration Thursday approved a new type of prostate-cancer treatment from Dendreon Corp. (DNDN).
The therapy, Provenge, is approved for certain men with advanced prostate cancer who've failed treatment with hormone therapy. Provenge is designed to use a patient's own cells to stimulate the body's immune system to fight the cancer.
In 2007, the FDA rejected Provenge despite a unanimous vote in favor of the treatment. At the time, FDA said the two clinical studies submitted didn't meet study goals of reducing so-called time to progression, or the advancement, of cancer. But an analysis of one of those studies showed those receiving Provenge lived about 4.5 months longer than men not receiving the treatment.
Still, the FDA asked for more data, which the Seattle-based Dendreon later submitted.
That data, which involved 512 patients, showed an increase in overall survival of 4.1 months among those receiving Provenge. The median survival for patients receiving Provenge treatments was 25.8 months, compared with 21.7 months for those who didn't receive the treatment.
The company's stock was halted for pending news at shortly after 12:30 p.m. EDT, but was trading up 15% at $45.50 at the time after earlier hitting a new high.
Prostate cancer is the second most common type of cancer among men in the U.S., behind skin cancer, and usually occurs in older men. In 2009, an estimated 192,000 new cases of prostate cancer were diagnosed and about 27,000 men died from the disease, according to the National Cancer Institute.
The FDA said almost all of the patients who received Provenge had some type of adverse reaction to the treatment, many of which were considered mild to moderate. Common side effects included chills, fatigue, fever, back pain, nausea, joint ache and headache.
However, serious side effects were reported in about 25% of patients and included infusion reactions and stroke. The FDA said strokes were seen in 3.5% of patients in the Provenge group compared with 2.6% of patients in the control group, or those who didn't receive Provenge.
The FDA explained that each dose of Provenge is manufactured by obtaining a patient's immune cells from the blood, using a machine in a process known as leukapheresis.
The immune cells are then exposed to a protein found in most prostate cancers and linked to an immune stimulating substance. Then the cells are returned to the patient to treat the prostate cancer. Provenge is administered intravenously in a three-dose schedule given at about two-week intervals.
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