Posted by Michael Wonder on 09 Feb 2018
Zytiga (abiraterone acetate) plus prednisone approved for treatment of earlier form of metastatic prostate cancer
8 February 2018 - Findings from pivotal Phase 3 LATITUDE clinical trial data demonstrated statistically significant and clinically meaningful improvements in patients.
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. FDA has approved a new indication for Zytiga (abiraterone acetate) in combination with prednisone for the treatment of patients with metastatic high-risk castration-sensitive prostate cancer (CSPC).
The approval is based on Phase 3 data from the pivotal LATITUDE clinical trial, which found that in patients with metastatic high-risk CSPC, Zytiga in combination with prednisone reduced the risk of death by 38% compared to placebos.
