A Seattle biotechnological company, said Wednesday it will apply for U.S. Food and Drug Administration approval to market Provenge, its prostate cancer vaccine, based on the survival benefit the treatment has shown in two clinical trials.
The announcement pushed the company's stock price up 12.7 percent, closing at $7.02 on the Nasdaq. After-hours trading lifted shares 23 cents more, or 3.3 percent.
Dendreon said it decided to seek approval for Provenge, which is designed to stimulate the body's immune system to attack prostate cancer, after learning from FDA officials that the vaccine's survival benefit and its relatively mild side effects were sufficient grounds on which to file a Biologics License Application.
A Phase 3 clinical study of 127 men with advanced prostate cancer found that those treated with Provenge lived an average 4.5 months longer than those given a placebo.
A second Phase 3 trial, detailed results of which are expected later this year, showed a "substantially greater" percentage of treated patients were alive after three years than those who got a placebo, reports Seattle Times.
According to the New York Times, several men with prostate cancer implored the committee to recommend approval because men with advanced disease have virtually no options other than a chemotherapy drug with severe side effects. More than 30,000 men in the United States die from prostate cancer each year.
But some of the panel members said that more study was needed.
"I don't think we ought to be swayed by an emotional appeal that there are thousands of people dying in pain and this drug will solve that problem or that it will cure them," said Dr. Michael C. Perry of the University of Missouri.
"It will do neither," he said, adding that approving the drug now would be an "absolute disservice" to patients by making it harder to conduct new clinical trials.
Abbott said in a statement that it would continue to study Xinlay, known generically as atrasentan, and that it believed it was effective.
Tarceva, the OSI drug known generically as erlotinib, did show a statistically significant benefit in its clinical trial. So the question for the committee was more a judgment as to whether that benefit was meaningful to doctors and patients, especially given that Tarceva did not appear to improve the quality of patients' lives and had side effects including diarrhea and an increased risk of stroke.
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