Clinical Labeling Update for Xtandi Under FDA Review

Clinical Labeling Update for Xtandi Under FDA Review
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.

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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.

For more information visit US.Astellas.com or Medivation.com.

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