Posted by Michael Wonder on 05 Jun 2019
Janssen seeks to expand use of Erleada (apalutamide) in the treatment of patients with metastatic hormone-sensitive prostate cancer
4 June 2019 - Application supported by data from the Phase 3 TITAN study which were recently presented at the 2019 ASCO Annual Meeting and simultaneously published in The New England Journal of Medicine.
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the submission of a Type II variation to the EMA seeking approval of Erleada (apalutamide) for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC), regardless of extent of disease or prior docetaxel treatment history.
The submission to the EMA follows the submission of supplemental registration dossiers to the U.S. FDA on 29 April 2019 and to the Japanese Ministry of Health, Labour and Welfare on 31 May 2019 seeking approval of a new indication for apalutamide for the treatment of patients with mHSPC.
