Mark D. Tyson II, M.D., MPH, discusses how recent updates to clinical guidelines now cautiously embrace bladder-sparing gene therapies like nadofaragene for patients with BCG-unresponsive non-muscle invasive bladder cancer, exploring the evolving treatment landscape, operational challenges, and real-world implementation strategies that are shifting the field toward more personalized, less invasive approaches while maintaining oncologic efficacy.
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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EP. 2: 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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EP. 3: Impact of Real-World Treatment Experience on Gene Therapy Uptake in NMIBC
July 28th 2025An expert discusses how real-world evidence is driving gene therapy adoption in BCG-unresponsive disease primarily through demonstrated durability and excellent tolerability, with 30% to 40% of patients achieving long-term disease-free survival despite the need for better comparative data to guide treatment selection.
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EP. 4: Navigating Challenges and Impact on Workflow with New NMIBC Therapies in Practice
July 28th 2025An expert discusses how integrating newer NMIBC therapies faces operational barriers including administration logistics, staff training and formulary restrictions, while solutions require better comparative data, institutional protocols and industry partnerships to overcome unwarranted practice variation.
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An expert discusses how clinics can successfully implement gene therapy workflows by establishing strong institutional protocols, assigning dedicated clinic coordinators, and using strategies like rectal diazepam premedication to prevent bladder spasms and medication loss during expensive treatments.
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EP. 6: Reducing Clinical Resource Burden: Impact of Less Frequent NMIBC Therapy Administration
August 4th 2025An expert discusses how less frequent administration of therapies like nadofaragene (every 90 days) significantly reduces clinical resource burden compared with combination treatments like gemcitabine-docetaxel, which require extensive logistics, chemotherapy-licensed staff and daily clinic visits.
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An expert discusses how community-based gene therapy administration has broadened treatment options for patients with BCG-unresponsive NMIBC by providing easier logistics compared with complex chemotherapy regimens, ultimately expanding bladder-sparing approaches and avoiding radical cystectomy in younger, sexually active patients.
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EP. 8: Understanding NMIBC and Its Risk Factors
August 18th 2025An expert discusses how non-muscle invasive bladder cancer (NMIBC) is a localized form of urothelial cell carcinoma that primarily affects older men with smoking as the primary risk factor, requiring close follow-up due to its highly recurrent nature.
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EP. 9: Navigating Treatment Burden in NMIBC
August 18th 2025An expert discusses how non-muscle invasive bladder cancer (NMIBC) creates a significant clinical and financial burden with up to 60% recurrence rates, affecting an estimated 85,000 new patients annually and requiring frequent office visits that impact quality of life for this older population.
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EP. 10: When BCG Falls Short: What’s Next for NMIBC Patients?
August 25th 2025An expert discusses how patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) now have several FDA-approved treatment options beyond radical cystectomy, including pembrolizumab, gene therapy and intravesical chemotherapy combinations.
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EP. 11: A New Era: The Rise of Gene Therapy in NMIBC
August 25th 2025An expert discusses how gene therapy represents a breakthrough treatment approach for BCG-unresponsive patients, offering quarterly dosing that reduces treatment burden while showing promising response rates of 50% to 70% in real-world evidence.
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EP. 12: Where Do We Go From Here? Overcoming Barriers in NMIBC Care
September 2nd 2025An expert discusses how clinicians now face the exciting challenge of selecting optimal treatments from multiple new options for BCG-unresponsive patients, opening opportunities for clinical research to determine the best sequencing and patient-specific approaches.
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