Zytiga Submitted For FDA Approval Pre Chemotherapy

Janssen Submits Additional Marketing Applications for ZYTIGA® in the European Union and in the U.S.



Simultaneous Submissions Based on Data from Pre-chemo Prostate Cancer Study

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. Food and Drug Administration (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.
"We're delighted to move forward so quickly with these regulatory submissions, building on the momentum created by the data presentation two weeks ago," said Michael L. Meyers, M.D., Ph.D., Vice President, Compound Development Team Leader, ZYTIGA.  "We look forward to working with the FDA and EMA to make ZYTIGA available for men with metastatic prostate cancer earlier in the course of their disease."
The company previously announced the study was unblinded based on the unanimous recommendation of an Independent Data Monitoring Committee (IDMC).  Based on these results, the IDMC also recommended that patients in the control arm be offered treatment with ZYTIGA.
"As a company, we strive to develop innovative therapeutic options that meet the unmet needs of patients suffering from devastating diseases such as mCRPC," said William N. Hait, M.D., Ph.D., Global Head, Janssen Research & Development and Head, Oncology Therapeutic Area.  "These regulatory submissions for ZYTIGA are a clear example of our efforts to bring extraordinary oncologic therapies to those with the greatest need."