Pfizer says FDA grants XTANDI application priority review
Astellas Pharma and Pfizer announced that the U.S. Food and Drug Administration has accepted for review the filing of a supplemental New Drug Application for XTANDI to add an indication for the treatment of men with metastatic hormone-sensitive prostate cancer. The application has also been granted Priority Review, a designation given to those applications for drugs that, if approved, may offer significant improvements in the safety or effectiveness of the treatment, diagnosis or prevention of serious conditions when compared to standard applications. XTANDI is currently indicated in the U.S. for the treatment of patients with castration-resistant prostate cancer. The submission is based on results from the Phase 3 ARCHES trial presented at the 2019 Genitourinary Cancers Symposium in February and published in The Journal of Clinical Oncology in July 2019. The study evaluated the efficacy and safety of XTANDI plus androgen deprivation therapy versus ADT plus placebo in men with mHSPC. The primary endpoint of radiographic progression-free survival was met in the study.