J&J Janssen Cilag submits supplemental applications to extend use of Zytiga in Prostate Cancer - 16-Jun-2012

J&J Janssen Cilag International has submitted a type II variation to the EMA for Zytiga (abiraterone acetate). Simultaneously, Janssen Research & Development submitted a supplemental New Drug Application to the FDA. Both applications are intended to extend the use of Zytiga administered with prednisone for patients with metastatic castration resistant Prostate Cancer (mCRPC) who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy and before chemotherapy. This follows results from interim analyses of the Phase III COU-AA-302 study of 1,088 asymptomatic or mildly symptomatic men with mCRPC who had not received chemotherapy. The study was unblinded following a unanimous recommendation of an Independent Data Monitoring Committee (IDMC). The IDMC also recommended that patients in the control arm be offered treatment with Zytiga.