Enzalutamide (commercially known as XTANDI) , a medication developed by Astellas Pharma Inc. and Pfizer Inc., has been approved by the U.S. Food and Drug Administration (FDA) for treating a specific type of prostate cancer. This approval is based on a study called the EMBARK trial, that our research team joined in 2016, which showed that XTANDI can help delay the spread of cancer or death in men with nonmetastatic castration-sensitive prostate cancer (nmCSPC) who have a high risk of their cancer spreading. Previously, options for these patients were limited. XTANDI can now be used alone or with another therapy called a gonadotropin-releasing hormone (GnRH) analog. This approval offers new hope for patients and caregivers dealing with this challenging disease. The EMBARK trial focused on men who had already been treated for prostate cancer but experienced a recurrence with a high risk of the cancer spreading. XTANDI works by blocking signals in the body that promote cancer growth. It’s been shown to be effective in various stages of prostate cancer, and this approval expands its use to help more patients in need.
Thanks to Dr. Gotto and our entire research team for their hard work on this trial. Their dedication to advancing medical science and improving patient outcomes is remarkable. This success is a direct result of their efforts and highlights the critical role our clinical research team plays in bringing groundbreaking therapies to the market and providing patients with the best care.