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# Xtandi sNDA Accepted for Review
- URL: https://www.fdaweb.com/xtandi-snda-accepted-for-review/
- Published: 2016-02-23T12:00:00.000Z
- Updated: 2026-09-15T02:38:11.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5134859

> FDA has accepted for review a Medivation and Astellas Pharma supplemental NDA for Xtandi (enzalutamide) capsules, indicated for treating metastatic castration-resistant prostate cancer (mCRPC). The submission includes findings from the Phase 2 TERRAIN and STRIVE studies, and seeks to update the relevant clinical sections within the current indication. The agency has set a user fee goal date of 10/22.  
>  
> The Phase 2 TERRAIN trial enrolled 375 patients in North America and Europe, according to the companies. The trial was designed to evaluate enzalutamide at a dose of 160 mg taken orally once daily versus bicalutamide at a dose of 50 mg taken once daily, the approved dose in combination with a luteinizing hormone-releasing hormone (LHRH) analog therapy. The primary endpoint of the trial was progression-free survival (PFS), defined as time from randomization to centrally confirmed radiographic progression, skeletal-related event, initiation of new anti-neoplastic therapy or death, whichever occurred first.  
>  
> The STRIVE trial enrolled 396 patients in the U.S. It randomized 257 patients with metastatic prostate cancer and 139 patients with non-metastatic prostate cancer whose disease progressed despite treatment with a LHRH analog therapy or following surgical castration, the companies say. The primary endpoint of the trial was PFS, defined as time from randomization to radiographic (bone or soft tissue) progression, prostate-specific antigen (PSA) progression (defined by Prostate Cancer Working Group 2 criteria), or death due to any cause, whichever occured first. The trial was designed to evaluate enzalutamide at a dose of 160 mg taken once daily (n=198) versus bicalutamide at a dose of 50 mg taken once daily (n=198).