A supplemental New Drug Application (sNDA) for Xtandi (enzalutamide), an oral capsule and product of pharmaceutical companies Astellas Pharma Inc. and Medivation Inc. has been accepted for review by the U.S. Food and Drug Administration (FDA).
The new application will include data collected during two phase-two studies: Terrain, which focused on 375 patients in North America and Europe, and Strive -- 396 patients in the U.S. The primary endpoint of both trials was progression-free survival.
Xtandi is already FDA-approved for the treatment of mCRPC. A decision on the new application is expected on or before Oct. 22. It works by blocking steps in the androgen receptor and signaling pathway in tumor cells.
Astellas is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products.