Janssen Research and Development has received the Priority Review for the supplemental New Drug Application (sNDA) for ZYTIGA from US Food and Drug Administration (FDA).
Zytiga (abiraterone acetate) is administered in combination with prednisone to treat patients with metastatic castration-resistant prostate cancer (mCRPC) who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy.
The FDA grants Priority Review to medicines, which progress in treatment or provide a treatment option where no adequate therapy exists.
Janssen vice president and Zytiga compound development team leader Michael Meyers said, "We believe that men with mCRPC whose disease is asymptomatic or mildly symptomatic, for whom chemotherapy may not be immediately necessary, have limited treatment options and that this disease setting represents a critical unmet medical need."
In April 2011, FDA approved Zytiga in combination with prednisone to treat patients with mCRPC who have received prior chemotherapy containing docetaxel.
