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By Jennifer Corbett Dooren
Of DOW JONES NEWSWIRES
WASHINGTON -(Dow Jones)- The Food and Drug Administration Tuesday questioned the effectiveness of a proposed prostate-cancer treatment from Dendreon Corp. (DNDN).
The agency said two studies of the proposed drug, Provenge, failed to meet both primary and secondary endpoints in documents posted to its Web site. The drug faces a review on Thursday by an outside panel of medical experts who are being asked to make recommendations about whether the agency should approve Provenge.
However, the FDA also said, "It appears that the two studies provide some evidence in support of using Provenge for the treatment of men with...(advanced) prostate cancer." One type of analysis conducted in one of the studies showed that patients receiving Provenge lived on average about four months longer than cancer patients not receiving the drug.
The Seattle-based company is asking the FDA to approve Provenge to treat men with advanced prostate cancer who stopped responding to hormone therapy. If approved, Provenge would be a first-of-a-kind treatment for cancer because the drug is designed to stimulate a person's immune system to fight the cancer.
In its briefing document, also posted to the FDA's Web site, Dendreon noted Provenge is "very well tolerated" and "has well characterized and manageable known risks."
The only other treatment for advanced prostate cancer that's been shown to improve overall survival is Taxotere, a chemotherapy drug from Sanofi-Aventis (SNY). Chemotherapy drugs often have significant side-effects including nausea, vomiting, anemia and infection that can make them hard for patients to tolerate.
The FDA agreed with Dendreon that Provenge was "generally well tolerated," with the most prominent side-effects being fever, chills and fatigue. However, the FDA said it was concerned about an increased number of strokes among patients treated with Provenge compared with patients who didn't get the drug.
The FDA said it would ask the panel whether a 3.9% stroke rate seen among Provenge patients - compared with a 2.6% rate among patients in the placebo groups - was a "potential safety signal" for Provenge.
The panel is being asked to vote on questions about whether it thinks Provenge is safe and effective. The FDA usually follows its panel's advice but is not bound by it. The FDA is scheduled to make a final decision on Provenge by mid-May.
Dendreon shares recently traded at $4.78, up 24 cents, or 5.3%. Volume stood at almost three times its daily average.
- By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; Jennifer.Corbett@dowjones.com
(END) Dow Jones Newswires
03-27-07 1210ET
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