Dendreon Corporation announced the positive results of its pivotal Phase 3 study (D9901) of PROVENGE® (sipuleucel-T) in men with advanced androgen-independent prostate cancer.
These results demonstrating the significant survival benefit and favorable safety profile of PROVENGE® are published in the July issue of the Journal of Clinical Oncology.
PROVENGE® is Dendreon Corp.’s investigational active cellular immunotherapy which the company plans to submit a Biologics License Application (BLA) of, to the USFDA later this year to obtain approval for marketing.
Read more at Dendreon Corp."This trial is an important milestone in the development of new treatments for prostate cancer patients. The survival benefit that was observed has the potential to offer important benefits to patients, and represents the first time an immunotherapy has provided a survival advantage in prostate cancer," said Eric J. Small, M.D., professor of medicine and urology at the University of California, San Francisco and lead author of the publication.
"In addition to the observed survival benefit, PROVENGE® has a very favorable toxicity and safety profile, with the most common side effects being low grade fevers and chills. A favorable benefit-to-risk profile will be appealing to patients with advanced stage prostate cancer who currently have few appealing treatment options available to them."
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