sNDA Submitted for Zytiga Plus Prednisone for Metastatic Castration Resistant Prostate Cancer

Janssen Research & Development submitted a supplemental New Drug Application (sNDA) to extend the use of Zytiga (abiraterone acetate) 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.

The regulatory application follows 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. 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.

Zytiga in combination with prednisone was approved by the FDA in April 2011 for the treatment of men with mCRPC who have received prior chemotherapy containing docetaxel.

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