Clinical Labeling Update for Xtandi Under FDA Review
Astellas and Medivation announced that the Food and Drug Administration (FDA) has accepted for review a supplemental New Drug Application (sNDA) for Xtandi (enzalutamide) capsules in metastatic castration-resistant prostate cancer (mCRPC), to update its labeling within the current indication.
The sNDA submission included data from the Phase 2 TERRAIN and STRIVE studies which provided clinical updates for mCRPC patients treated with enzalutamide. The TERRAIN study evaluated enzalutamide 160mg once daily vs. bicalutamide 50mg once daily, in combination with a luteinizing hormone-releasing hormone (LHRH) analogue, in 375 patients whose disease progressed despite LHRH analogue therapy or post surgical castration. The primary endpoint 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.
The STRIVE study evaluated enzalutamide 160mg once daily vs. bicalutamide 50mg once daily, in combination with a LHRH analogue, in 396 CRPC patients (257 metastatic, 139 non-metastatic) whose disease progressed despite treatment with a LHRH analogue therapy or post surgical castration. The primary endpoint 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.
The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of October 22, 2016 to make a decision for the sNDA.
Xtandi is an androgen receptor inhibitor.