FDA Expands Xtandi Approval to Include Metastatic Castration-sensitive Prostate Cancers

FDA Expands Xtandi Approval to Include Metastatic Castration-sensitive Prostate Cancers
The U.S. Food and Drug Administration (FDA) has agreed to expand Xtandi's (enzalutamide) approval to include men whose metastatic prostate cancer still responds to hormone therapy, Astellas Pharma and Pfizer, the treatment's developers, announced. The recent approval, which covers men with metastatic castration-sensitive prostate cancer (mCSPC), follows approvals for non-metastatic and metastatic castration-resistant prostate cancers, making Xtandi the first oral treatment approved in the U.S. for these three types of advanced prostate cancer. "Xtandi has been established as a standard of care for men with castration-resistant prostate cancer and has been prescribed to more than 420,000 patients worldwide since it was first approved in 2012," Andrew Krivoshik, MD, PhD, senior vice president and oncology therapeutic area head at Astellas, said in a press release. "This approval in metastatic castration-sensitive prostate cancer means physicians can now offer Xtandi to men earlier in their advanced prostate cancer treatment journey." Metastasis is a major cause of complications and death among men with prostate cancer. Once prostate cancer spreads, patients tend to have a poor prognosis, even if their cancer still responds to hormone therapy. Xtandi 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 decision to approve Xtandi for men with mCSPC was based on data from the ARCHES Phase 3 trial (NCT02677896), where a combination of Xtandi and standard androgen deprivation therapy (ADT) lowered the risk of radiographic disease progression by 61%, compared to A
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