Merck wins FDA priority review for KEYTRUDA bladder cancer combo expansion
If approved, the move would significantly broaden the use of KEYTRUDA and KEYTRUDA QLEX in combination with Padcev
If approved, the move would significantly broaden the use of KEYTRUDA and KEYTRUDA QLEX in combination with Padcev
A decision is expected by August 17, 2026 under the Prescription Drug User Fee Act timeline
FGFR alterations are prevalent in early-stage bladder cancer, appearing in roughly 70% of intermediate-risk and 40% of high-risk NMIBC tumors
The study showed a 76% complete response (CR) rate at 12 months, rising to 95% at any time for high-risk NMIBC patients
The funding will be spread over four years, with BXLS also eligible for regulatory and commercial milestones, plus royalties on worldwide sales
CystoSmart, an AI tool designed to detect bladder tumors during screening and surveillance cystoscopy, is brand-agnostic and works with flexible, rigid, and single-use scopes
TactiFlex, the world’s first catheter with a flexible tip and contact?force sensing, allows doctors to deliver energy precisely and safely.
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