Rethinking First-Line Treatments: Will BCG Continue to Be the Standard in NMIBC?

EP: 1.Current Standards of Care and Shifting Strategies in NMIBC

EP: 2.NMIBC Treatment Decisions in the Age of BCG Shortages

EP: 3.Expert Discussion on BCG-Unresponsive NMIBC

EP: 4.Bladder-Sparing Breakthroughs: Novel FDA-Approved Treatment Options for NMIBC

EP: 5.Weighing the Risks and Benefits of Bladder-Sparing Agents vs Cystectomy

EP: 6.What’s Next for NMIBC: The Immunotherapy and Gene Therapy Pipeline

EP: 7.Topline Data From the BOND-003 Trial in NMIBC

EP: 8.Immunotherapy in NMIBC: Key Results Safety Profile From BOND-003 Trial

EP: 9.Diving Deeper: Discussing Results From Cohort C in the BOND-003 Trial

EP: 10.Ongoing Investigations: Expanding the Role of Cretostimogene in NMIBC Care

EP: 11.In the Pipeline: Novel Treatment Delivery Methods for NMIBC

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EP: 12.Rethinking First-Line Treatments: Will BCG Continue to Be the Standard in NMIBC?

The landscape of treatment for non–muscle-invasive bladder cancer (NMIBC) is evolving rapidly, with multiple new agents emerging alongside the long-established BCG therapy. While BCG monotherapy has been the standard first-line treatment, particularly for intermediate- and high-risk patients, its role is increasingly being reconsidered. For lower intermediate-risk disease, many experts believe the era of BCG monotherapy may be waning, reflecting changes in clinical practice and guidelines. However, for high-risk NMIBC, the picture remains less clear. Several ongoing trials are exploring combinations of BCG with novel immunotherapies and gene therapies, showing promising results that could potentially improve outcomes beyond what BCG alone has traditionally offered.

The shift in treatment paradigms also raises important considerations around toxicity and cost. Some new therapies, such as checkpoint inhibitors combined with BCG, offer improved recurrence-free survival but come with higher rates of immune-related adverse effects. Moreover, the financial impact of introducing these expensive agents is a significant concern, especially given the already high costs associated with bladder cancer management, including repeated surgeries and surveillance. Payers and health care systems may increasingly demand clear evidence of cost-effectiveness before widely endorsing these new options. As a result, BCG’s affordability, long history of use, and familiarity among urologists suggest it will likely remain a cornerstone of treatment for the foreseeable future, particularly while the shortage of BCG persists.

Going forward, a more refined approach to patient selection will be critical. Enhanced risk stratification using biomarkers and other clinical factors may help identify which patients benefit most from traditional BCG versus newer therapies or combination regimens. This precision medicine approach could optimize treatment efficacy while balancing toxicity and costs. Meanwhile, efforts to address BCG shortages—such as the introduction of recombinant BCG strains—are underway and may improve availability. Ultimately, the treatment of NMIBC in the next decade will likely involve multiple therapeutic options tailored to individual patient risk profiles, rather than a one-size-fits-all reliance on BCG alone.