Janssen submits supplemental applications for prostate cancer therapy

June 27, 2012

Janssen Research & Development, LLC recently submitted a supplemental new drug application to the FDA for abiraterone acetate (ZYTIGA) intended to extend the use of abiraterone administered with prednisone to include 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.

Janssen Research & Development, LLC recently submitted a supplemental new drug application to the FDA for abiraterone acetate (ZYTIGA) intended to extend the use of abiraterone administered with prednisone to include 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.

Simultaneously, Janssen-Cilag International NV submitted a similar type II variation to the European Medicines Agency.

Both regulatory applications follow the announcement of results observed from pre-specified interim analyses of the international phase III, randomized, double-blind, placebo-controlled COU-AA-302 clinical study. The study, which included 1,088 asymptomatic or mildly symptomatic men with metastatic, castration-resistant prostate cancer who had not received chemotherapy, found that abiraterone plus prednisone produced a statistically significant improvement in radiographic progression-free survival and a trend for increased overall survival. Results were presented at the American Society of Clinical Oncology annual meeting in Chicago.

Abiraterone acetate is currently approved for the treatment of men with metastatic, castration-resistant prostate cancer who have received prior treatment with docetaxel (Taxotere).

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