FDA Accepts New Drug Application for Enzalutamide in Metastatic Hormone-Sensitive Prostate Cancer
Posted: Tuesday, August 27, 2019
On August 21, 2019, the U.S. Food and Drug Administration (FDA) accepted for review the filing of a supplemental new drug application for enzalutamide (Xtandi) to add an indication for the treatment of men with metastatic hormone-sensitive prostate cancer. The application has also been granted Priority Review. Enzalutamide is currently indicated in the United States for the treatment of patients with castration-resistant prostate cancer.
The submission is based on results from the phase III ARCHES trial (ClinicalTrials.gov identifier NCT02677896) presented at the 2019 Genitourinary Cancers Symposium (Abstract 687) and published in the Journal of Clinical Oncology. The study evaluated the efficacy and safety of enzalutamide plus androgen-deprivation therapy (ADT) versus ADT plus placebo in men with metastatic hormone-sensitive prostate cancer. The primary endpoint of radiographic progression-free survival was met in the study.
Additionally, the submission is supported by data from the phase III ENZAMET trial (NCT02446405). The ENZAMET trial evaluated enzalutamide plus ADT versus ADT plus a standard nonsteroidal antiandrogen therapy (bicalutamide, nilutamide, or flutamide) in men with metastatic hormone-sensitive prostate cancer to provide an active control. The results were presented during the Plenary Session at the 2019 American Society of Clinical Oncology Annual Meeting (Abstract LBA2) and simultaneously published in The New England Journal of Medicine. The primary endpoint of overall survival was met in the ENZAMET trial. The safety analyses of the ARCHES and ENZAMET trials appear consistent with the safety profile of enzalutamide in previous clinical trials in castration-resistant prostate cancer.