FDA approves mitomycin intravesical solution for recurrent LG-IR-NMIBC

非肌肉浸润性膀胱癌（NMIBC）是膀胱癌最常见的类型，其中低级别中度风险NMIBC（LG-IR-NMIBC）患者面临着高复发率的挑战，需要反复进行经尿道膀胱肿瘤切除术（TUBT），给患者带来痛苦和医疗负担。FDA于2025年6月12日批准了丝裂霉素膀胱内注射液（Zusduri;原名UGN-102）用于治疗复发性LG-IR-NMIBC，为这类患者提供了首个经FDA批准的药物治疗选择，具有重要的临床意义。

该批准基于III期CLARION试验（NCT 05243550）的积极结果。该试验结果显示，Zusduri在首次滴注治疗后3个月的完全缓解率高达78%，12个月和18个月的完全缓解率分别为79%和80.6%。该疗法推荐剂量为75毫克（56毫升），每周一次通过导管滴入膀胱，持续6周。最常见的治疗相关不良事件包括排尿困难、排尿、尿路感染、小便和疲劳，严重不良事件发生率为12%，主要为尿潴留和尿路狭窄。

Zusduri的获批为复发性LG-IR-NMIBC患者提供了非手术治疗的新选择，有望减少TUBT的次数，改善患者生活质量。虽然FDA肿瘤药物咨询委员会曾对该药物的获益-风险特征投反对票，但最终FDA仍批准了该药物，体现了其临床价值。CLARION试验正在进行中，以进一步评估Zusduri的长期安全性和有效性。未来需要更多研究探索Zusduri在不同NMIBC亚型中的应用，并与现有治疗方案进行比较，以确定其最佳的临床定位。

来源: urologytimes

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参考文献

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