Applying Evidence Standards to Guide Gene Therapy Use in BCG-Unresponsive NMIBC
July 17th 2025An expert discusses how high-cost gene therapies require evidence standards including Phase 3 trial data showing complete response rates and durability, real-world evidence and health economic analyses to guide clinical use and coverage determinations before payers scrutinize their carte blanche approval.
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An expert discusses how recent updates to AUA, EAU and NCCN guidelines have cautiously shifted toward more bladder-sparing approaches for BCG-unresponsive patients, incorporating new FDA-approved therapies as conditional recommendations for those unwilling or unable to undergo radical cystectomy.
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