Posted by Michael Wonder on 18 Sep 2017
Janssen submits supplemental new drug application to U.S. FDA for Zytiga (abiraterone acetate) to treat men with earlier stages of metastatic prostate cancer
14 September 2017 - Filing supported by data from pivotal LATITUDE trial evaluating Zytiga in combination with prednisone and androgen deprivation therapy.
Janssen today announced the submission of a supplemental new drug application to the U.S. FDA seeking to expand the indication of Zytiga in combination with prednisone and androgen deprivation therapy (ADT) to include treatment of patients with high-risk metastatic hormone naïve prostate cancer or newly diagnosed, high-risk metastatic hormone sensitive prostate cancer (HSPC).
The filing is based on Phase 3 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 and radiographic progression-free survival, compared to placebo plus ADT.
