Request for Xtandi to Treat Metastatic Hormone-sensitive Prostate Cancer Before FDA

Request for Xtandi to Treat Metastatic Hormone-sensitive Prostate Cancer Before FDA
The U.S. Food and Drug Administration (FDA) has agreed to review Astellas Pharma and Pfizer's application for Xtandi (enzalutamide), requesting its approved use be expanded to include men whose metastatic prostate cancer still responds to hormone therapy. The supplemental new drug application, covering men with metastatic hormone-sensitive prostate cancer (mHSPC) in the U.S., was granted priority review. A decision is expected in the final months of 2019. "We are pleased to receive the priority review designation, which reflects the need for more treatment options for men living with metastatic hormone-sensitive prostate cancer," Chris Boshoff, MD, PhD, chief development officer of Oncology at Pfizer Global Product Development, said in a press release. "The submission is supported by a strong data package, including two Phase 3 trials investigating Xtandi in men living with this form of prostate cancer." Xtandi, developed by Pfizer and Astellas Pharma, is a form of hormone therapy that aims to prevent male hormones from sending chemical signals that stimulate cancer growth; it does so by blocking the activity of their receptor. The treatment was developed for advanced forms of prostate cancer. The FDA approved Xtandi's use in men with late-stage castration-resistant prostate cancer (CRPC) in 2012. Now, Pfizer and Astellas are requesting that its label also include men with mHSPC. The submission was based on data from two Phase 3 trials — ARCHES (NCT02677896) and ENZAMET (NCT02446405) — assessing the safety and efficacy of Xtandi in combination with androgen deprivation therapy (ADT), compared to ADT alone, or with a standard nonsteroidal anti-androgen therapy in this patient group. Findings from ARCHES, a company sponsored trial, were recent
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