Posted by Michael Wonder on 18 Sep 2019
U.S. FDA approves supplemental new drug application for Erleada (apalutamide) for the treatment of patients with metastatic castration-sensitive prostate cancer
17 September 2019 - Phase 3 TITAN is the first registrational study to achieve statistical significance in dual primary endpoints of overall survival and radiographic progression-free survival in patients with metastatic castration-sensitive prostate cancer regardless of extent of disease.
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. FDA has approved Erleada (apalutamide) for the treatment of patients with metastatic castration-sensitive prostate cancer.
Today's approval follows FDA priority review designation of the supplemental new drug application that was submitted in April 2019 and reviewed through the FDA Real-Time Oncology Review program.
