12.12.2014, 08:08
Phase 3 PREVAIL Trial Named Clinical Advance of the Year by Scrip
OREANDA-NEWS. Medivation, Inc. (NASDAQ: MDVN) and Astellas Pharma Inc. (TSE: 4503) today announced that PREVAIL, the global Phase 3 trial of enzalutamide in metastatic castration-resistant prostate cancer (CRPC), was named the Clinical Advance of the Year by SCRIP, a leading pharmaceutical industry publication.
XTANDI® (enzalutamide) capsules is approved in the United States and Europe for the treatment of patients with metastatic CRPC and in Japan for the treatment of patients with CRPC. The companies are also conducting investigational studies of enzalutamide in prostate cancer and advanced breast cancer.
“The PREVAIL trial results have supported successful applications to extend the label of XTANDI to metastatic CRPC patients who are chemotherapy-naïve, marking a significant step forward in the treatment of this common cancer,” SCRIP noted.
The annual SCRIP Awards acknowledge the biopharmaceutical industry’s most noteworthy achievements and milestones. This year’s winners were announced at the SCRIP 10th Anniversary Awards celebration in London.
About PREVAIL
The Phase 3 PREVAIL trial was a randomized, double-blind, placebo-controlled, multi-national trial that enrolled more than 1,700 patients at sites around the world. The trial enrolled patients with metastatic prostate cancer whose disease progressed despite treatment with androgen deprivation therapy and had not yet received chemotherapy. The trial was designed to evaluate enzalutamide at a dose of 160 mg taken orally once daily versus placebo plus gonadotropin-releasing hormone (GnRH) therapy or after bilateral orchiectomy. Targeted enrollment was completed in May 2012 and the interim analysis was pre-specified after 516 events (patient deaths).
In October 2013, the Independent Data Monitoring Committee (IDMC) reported positive results from the interim analysis of the PREVAIL trial and determined that given the overall survival benefit and the observed safety profile, the overall benefit-risk ratio favored the enzalutamide arm. The IDMC recommended unequivocally that patients receiving placebo be offered treatment with enzalutamide. Therefore, the PREVAIL trial was halted and patients receiving placebo were offered enzalutamide. The trial met both co-primary endpoints of overall survival and radiographic progression-free survival.
About XTANDI® (enzalutamide) capsules
XTANDI is approved by the U.S. Food and Drug Administration and the European Medicines Agency for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC). It is also approved in Japan for the treatment of patients with castration-resistant prostate cancer (CRPC).
XTANDI® (enzalutamide) capsules is approved in the United States and Europe for the treatment of patients with metastatic CRPC and in Japan for the treatment of patients with CRPC. The companies are also conducting investigational studies of enzalutamide in prostate cancer and advanced breast cancer.
“The PREVAIL trial results have supported successful applications to extend the label of XTANDI to metastatic CRPC patients who are chemotherapy-naïve, marking a significant step forward in the treatment of this common cancer,” SCRIP noted.
The annual SCRIP Awards acknowledge the biopharmaceutical industry’s most noteworthy achievements and milestones. This year’s winners were announced at the SCRIP 10th Anniversary Awards celebration in London.
About PREVAIL
The Phase 3 PREVAIL trial was a randomized, double-blind, placebo-controlled, multi-national trial that enrolled more than 1,700 patients at sites around the world. The trial enrolled patients with metastatic prostate cancer whose disease progressed despite treatment with androgen deprivation therapy and had not yet received chemotherapy. The trial was designed to evaluate enzalutamide at a dose of 160 mg taken orally once daily versus placebo plus gonadotropin-releasing hormone (GnRH) therapy or after bilateral orchiectomy. Targeted enrollment was completed in May 2012 and the interim analysis was pre-specified after 516 events (patient deaths).
In October 2013, the Independent Data Monitoring Committee (IDMC) reported positive results from the interim analysis of the PREVAIL trial and determined that given the overall survival benefit and the observed safety profile, the overall benefit-risk ratio favored the enzalutamide arm. The IDMC recommended unequivocally that patients receiving placebo be offered treatment with enzalutamide. Therefore, the PREVAIL trial was halted and patients receiving placebo were offered enzalutamide. The trial met both co-primary endpoints of overall survival and radiographic progression-free survival.
About XTANDI® (enzalutamide) capsules
XTANDI is approved by the U.S. Food and Drug Administration and the European Medicines Agency for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC). It is also approved in Japan for the treatment of patients with castration-resistant prostate cancer (CRPC).
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