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news.The US Food and Drug Administration (FDA) has accepted for review a supplemental new drug application (sNDA) submitted by Medivation and Astellas Pharma for Xtandi (enzalutamide) capsules in metastatic castration-resistant prostate cancer (mCRPC).
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The sNDA includes findings from the phase 2 Terrain and Strive studies, to update the appropriate clinical sections within the existing indication.
The FDA approved enzalutamide to treat patients with mCRPC. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the agency is 22 October 2016.
Medivation and Astellas Pharma have submitted a Type-II variation to update the Summary of Product Characteristics (SmPC) to the European Medicines Agency.
Under the phase 2 Terrain trial, the companies enrolled 375 patients in North America and Europe with metastatic prostate cancer whose disease progressed despite treatment with a luteinizing hormone-releasing hormone (LHRH) analogue therapy or after surgical castration.
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 trial was designed to assess 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 an LHRH analogue.
Under the phase 2 Strive trial, 396 CRPC patients were enrolled in the US. The trial randomized 257 patients with metastatic prostate cancer and 139 patients with non-metastatic prostate cancer whose disease progressed despite treatment with a LHRH analogue therapy or after surgical castration.
The trial’s 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, whichever occurs first.
It 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), the approved dose in combination with a LHRH analogue.