Zytiga (abiraterone) in combination with prednisone and ADT filed with FDA for supplemental New Drug Application in metastatic hormone na�ve prostate cancer or newly diagnosed, high-risk metastatic hormone sensitive prostate cancer.- Janssen Biotech.

Janssen Biotech announced the submission of a supplemental New Drug Application (sNDA) to the FDA seeking to expand the indication of Zytiga (abiraterone) in combination with prednisone and ADT to include treatment of patients with high-risk metastatic hormone naïve prostate cancer (HNPC) or newly diagnosed, high-risk metastatic hormone sensitive prostate cancer (HSPC).

The filing is based on Phase III data from the pivotal LATITUDE clinical trial, which found that in newly diagnosed patients with high-risk mHNPC, Zytiga in combination with prednisone and ADT significantly increased overall survival (OS) and radiographic progression-free survival (rPFS), compared to placebo plus ADT.

The LATITUDE study showed Zytiga in combination with prednisone and ADT reduced the risk of death by 38 percent compared to placebo plus ADT (median OS not reached vs. 34.7 months, respectively) in patients with mHNPC. Additional study results found patients with mHSPC who received Zytiga in combination with prednisone and ADT had a 53 percent lower risk of radiographic progression or death, compared to placebo plus ADT (median rPFS 33.0 months vs. 14.8 months, respectively. Concerning the secondary end points, Zytiga in combination with prednisone and ADT, reduced the risk of pain progression by 31 percent and skeletal-related events by 30 percent and reduced the risk of needing to start chemotherapy by 56 percent compared to placebo plus ADT.