Posted by Michael Wonder on 01 May 2019
Janssen submits application to U.S. FDA seeking approval of Erleada (apalutamide) for patients with metastatic castration-sensitive prostate cancer
29 April 2019 - Supplemental new drug application supported by Phase 3 TITAN study; submitted through FDA real-time oncology review program.
Janssen announced today the submission of a supplemental new drug application to the U.S. FDA seeking approval of a new indication for Erleada (apalutamide) for the treatment of patients with metastatic castration-sensitive prostate cancer.
The application is based on findings from the Phase 3 TITAN study, whose dual primary endpoints, overall survival and radiographic progression-free survival, were both achieved. These data will be presented at the upcoming American Society of Clinical Oncology Annual Meeting during an oral abstract session on Friday, May 31st.
