Supplemental New Drug Application Submitted for Abiraterone

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Janssen Research & Development, LLC, has submitted a supplemental New Drug Application (sNDA) to the FDA to extend the use of abiraterone acetate (Zytiga) administered with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy and before chemotherapy.

The application follows the announcement of results observed from prespecified interim analyses of the international phase III, randomized, double-blind, placebo-controlled COU-AA-302 clinical trial. This study, which included 1,088 asymptomatic or mildly symptomatic men with metastatic castration-resistant prostate cancer who had not received chemotherapy, evaluated the effect of abiraterone plus prednisone on the coprimary endpoints of radiographic progression-free survival and overall survival compared to placebo plus prednisone. Data from this study were presented at the 48th ASCO Annual Meeting in June.

The company previously announced the study was unblinded based on the unanimous recommendation of an Independent Data Monitoring Committee. Based on these results, the committee also recommended that patients in the control arm be offered treatment with abiraterone. ■




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