ERLEADA™ (apalutamide) is an androgen receptor inhibitor indicated for the treatment of patients with non-metastatic castration-resistant prostate cancer.
As Smith et al showed, among men with nonmetastatic castration-resistant prostate cancer, metastasis-free survival and time to symptomatic progression were significantly longer with apalutamide than with placebo.
Results from the phase III TITAN trial, presented by Chi et al at the 2019 ASCO Annual Meeting (Abstract 5006), showed that the addition of apalutamide to androgen-deprivation therapy (ADT) improved radiographic progression-free and overall survival in patients with metastatic castration-sensitive prostate cancer. There is a lack of clinical evidence regarding the effectiveness of this drug for this indication as published in the authoritative, peer-reviewed medical and scientific literature.
There is literature supporting its sue off-label for hormone-resistant cancer as well. However, the only phase III study is for apulutamide plus ADT in patients with castrate-sensitive metastatic disease and it showed overall increased survival over ADT alone. There is literature supporting its use off-label for hormone-resistant cancer as well. However, the only phase III study is for apulutamide plus ADT in patients with castrate-sensitive metastatic disease and it showed overall increased survival over ADT alone. However, NCCN lists ADT with apulutamide as an option.
Matthew R. Smith, M.D., Ph.D., Fred Saad, M.D., Simon Chowdhury, M.B., B.S., Ph.D., Stéphane Oudard, M.D., Ph.D., Boris A. Hadaschik, M.D., Julie N. Graff, M.D., David Olmos, M.D., Ph.D., Paul N. Mainwaring, M.B., B.S., M.D., Ji Youl Lee, M.D., Hiroji Uemura, M.D., Ph.D., Angela Lopez-Gitlitz, M.D., Géralyn C. Trudel, Ph.D., et al., for the SPARTAN Investigato, Apalutamide Treatment and Metastasis-free Survival in Prostate Cancer. N Engl J Med 2018; 378:1408-1418
https://www.ascopost.com/News/60096
Rathkopf DE et al, Safety and Antitumor Activity of Apalutamide (ARN-509) in Metastatic Castration-Resistant Prostate Cancer with and without Prior Abiraterone Acetate and Prednisone.Clin Cancer Res. 2017 Jul 15;23(14):3544-3551.
NCCN PROS-13 2024