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<p>Bacillus Calmette-Guérin (BCG) remains the cornerstone of therapy for high-risk non–muscle-invasive bladder cancer (NMIBC). However, up to 40% of patients develop BCG-unresponsive disease, where radical cystectomy remains the gold standard but is often unfeasible. During the past few years, multiple novel intravesical therapies have been developed, reshaping the management of BCG-unresponsive disease. The FDA approvals of pembrolizumab, nadofaragene firadenovec, BCG combined with the IL-15 superagonist N‑803, and the recently approved drug-delivery device TAR-200, alongside promising results of the oncolytic agent CG0070, mark a&#xa0;new era in bladder-sparing management. These therapies demonstrate clinically relevant efficacy with limited toxicity, redefining the treatment algorithm for BCG-unresponsive NMIBC.</p>

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Emerging therapies for BCG unresponsive non-muscle-invasive bladder cancer: an overview

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2026年2月20日

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  • Héctor Alfambra,
  • Enric Carbonell,
  • Antoni Vilaseca

摘要

Bacillus Calmette-Guérin (BCG) remains the cornerstone of therapy for high-risk non–muscle-invasive bladder cancer (NMIBC). However, up to 40% of patients develop BCG-unresponsive disease, where radical cystectomy remains the gold standard but is often unfeasible. During the past few years, multiple novel intravesical therapies have been developed, reshaping the management of BCG-unresponsive disease. The FDA approvals of pembrolizumab, nadofaragene firadenovec, BCG combined with the IL-15 superagonist N‑803, and the recently approved drug-delivery device TAR-200, alongside promising results of the oncolytic agent CG0070, mark a new era in bladder-sparing management. These therapies demonstrate clinically relevant efficacy with limited toxicity, redefining the treatment algorithm for BCG-unresponsive NMIBC.