Juan Gómez-Rivas, MD, discusses barriers to PSMA-PET imaging and how disparities in access may affect prostate cancer staging and treatment planning.
News|Articles|April 1, 2025
FDA updates in urology: March 2025
Author(s)Hannah Clarke
A recap of the FDA submissions and regulatory decisions in urology from March 2025.
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Welcome to Urology Times’® monthly FDA update! This month, key developments include the initiation of a pivotal trial in stress urinary incontinence (SUI), an expanded indication for radioligand therapy in metastatic castration-resistant prostate cancer (mCRPC), and the approval of a new treatment regimen in muscle-invasive bladder cancer (MIBC).
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The target enrollment goal has been reached in the phase 3 BiPASS study, evaluating PSMA-PET plus MRI for prostate cancer detection.
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A decision is expected by the fourth quarter of 2026.
Eugene Cone, MD, discusses SWOG S1602 findings comparing Tokyo-172 and TICE BCG and the potential role of alternative BCG strains in NMIBC
The study is assessing the safety and preliminary efficacy of CD28 co-stimulation in patients with mCRPC.
Eugene Cone, MD, discusses the impact of ongoing BCG supply challenges and the potential role of alternative and recombinant strains for NMIBC care.
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