Janssen submits sNDA to FDA for Zytiga to treat earlier stage of prostate cancer
Janssen Biotech, a Johnson & Johnson company, announced the submission of a supplemental New Drug Application, or sNDA, to the U.S. Food and Drug Administration seeking to expand the indication of Zytiga in combination with prednisone and ADT to include treatment of patients with high-risk metastatic hormone naive prostate cancer or newly diagnosed, high-risk metastatic hormone sensitive prostate cancer. In April, Janssen submitted a Type II variation application to the European Medicines Agency, seeking to expand the existing marketing authorization for Zytiga in combination with prednisone or prednisolone to include the treatment of men with mHNPC. Similar submissions have been made in Japan, Canada, Mexico, Brazil, Switzerland, Taiwan, Singapore, and the Philippines. If approved, these submissions will broaden the use of Zytiga in combination with prednisone or prednisolone to include an earlier stage of prostate cancer than its current indications.