Dec 17, 2019: Pfizer Inc. and Astellas Pharma Inc.recieves the FDA approved (first and only oral treatment) supplemental new drug application for enzalutamide (Xtandi) to treat men with metastatic castration-sensitive prostate cancer (mCSPC).
FDA approved enzalutamide with three distinct types of advanced prostate cancer: non-metastatic and metastatic castration-resistant prostate cancer (CRPC), and mCSPC.
The agency based its approval on results from the randomized phase III ARCHES trial which is designed to evaluate enzalutamide plus androgen deprivation therapy (ADT), compared with the placebo and ADT, in 1,150 men with mCSPC.
Across sites in the US, Canada, Europe, South America, and the Asia-Pacific region, patients were randomized to receive 160 mg of enzalutamide daily or placebo and continued on a luteinizing hormone-releasing hormone agonist or antagonist or had a history of bilateral orchiectomy. https://www.cancernetwork.com/news/fda-approves-enzalutamide-mcspc-treatment
