Prostate Cancer Treatment Vaccine for Advanced Cases In the Works April 16
A study to comply with the Food and Drug Administration’s request for additional information on the effects of the experimental prostate cancer treatment vaccine Provenge has been completed. Seattle-based biotech company Dendreon Corporation, developer of Provenge, has revealed that the trials yielded promising results, which may seal the deal towards FDA approval.
Provenge is a drug administered by infusion to patients suffering from advanced stages of prostate cancer whose cancers have been determined as unresponsive to anti-androgen treatments.
In 2007, the drug has been recommended for approval after review by an FDA advisory panel. However, the FDA chose to ask for additional data regarding Provenge’s contribution towards lengthening patient survival.
In response, Dendreon conducted a new study to determine whether Provenge treatment can significantly increase a patient’s chances for survival. The study was conducted using a test pool of 512 patients with advanced stage prostate cancer – patients whose cancers have already spread and are no longer responding to anti- androgen treatment. Results of the study showed that those who were given Provenge had significantly higher survival rates than those who were not administered with the drug. The results were consistent with the results of previous trials conducted using the drug, according to Dendreon president and CEO Mitchell Gold, MD. In addition, no new side effects from Provenge were noted.
If approved by the FDA, Provenge can become a potential treatment option for patients who are no longer responding to treatments after having undergone surgery or any other local therapy as well as anti-androgen therapy as a result of cancer recurrence.
Dendreon will present the study and their findings at the annual meeting of the American Urological Society in Chicago on April 28. The American Cancer Society has released a statement expressing interest in the results of the study, and that it is looking forward to the presentation. Dendreon intends to submit their findings to the FDA in the last quarter of 2009.
Tags: dendreon corp, prostate cancer, prostate cancer screening, prostate cancer treatment, provenge