Dendreon said that Provenge is the first autologous cellular immunotherapy to be approved by the FDA for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.
The analysis includes data from four randomized trials in patients with either metastatic castrate resistant prostate cancer or androgen dependent prostate cancer that were integrated to examine the safety profile of Provenge across the four studies.
The safety evaluation of Provenge was based on 601 prostate cancer patients in four randomized clinical trials who underwent at least one leukapheresis procedure.
Simon Hall, director of the Barbara and Maurice Deane Prostate Health and Research Center at Mount Sinai Medical Center, said: “The approval of Provenge provides us with an important new, front-line option for men with asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.”
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