J&J's (JNJ) Janssen-Cilag Submits Additional Marketing Application for ZYTIGA

June 15, 2012 8:04 AM EDT
Johnson & Johnson's (NYSE: JNJ) Janssen-Cilag International NV announced today it has submitted a type II variation to the European Medicines Agency (EMA) for ZYTIGA ^® ; simultaneously, Janssen Research & Development, LLC submitted a supplemental New Drug Application (sNDA) to the U.S. FDA; Both applications are intended to extend the use of ZYTIGA administered with prednisone for the treatment of patients with metastatic castration resistant prostate cancer (mCRPC) who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy and before chemotherapy.

Both regulatory applications follow the announcement of results observed from pre-specified interim analyses of the international Phase 3, randomized, double-blind, placebo-controlled COU-AA-302 clinical study. This study, which included 1,088 asymptomatic or mildly symptomatic men with mCRPC who had not received chemotherapy, evaluated the effect of ZYTIGA plus prednisone on the co-primary endpoints of radiographic progression-free survival (rPFS) and overall survival (OS) compared to placebo plus prednisone. Data from this study were presented at the 48th Annual Meeting of the American Society of Clinical Oncology (ASCO) earlier this month.

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