UroGen Pharma has received approval from the U.S. Food and Drug Administration (FDA) for ZUSDURI™ (mitomycin) for intravesical use, marking it as the first and only approved treatment for adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).

UroGen Pharma 已获得美国食品药品监督管理局 (FDA) 批准，将 ZUSDURI™（丝裂霉素）用于膀胱内治疗，这标志着它是首个也是唯一获批的用于治疗复发性低级别中危非肌层浸润性膀胱癌 (LG-IR-NMIBC) 成人患者的疗法。

ZUSDURI is administered by a healthcare professional in an outpatient setting using a urinary catheter. The formulation allows for the slow release of mitomycin within the bladder, enabling targeted treatment without surgery.

ZUSDURI由医疗专业人员在门诊环境中通过尿道导管给药。该制剂能够在膀胱内缓慢释放丝裂霉素，从而实现无需手术的靶向治疗。

Non-muscle invasive bladder cancer affects approximately 82,000 individuals in the U.S. annually, with around 59,000 of these being recurrent cases. Most patients are diagnosed later in life and may face multiple recurrences, making non-surgical alternatives particularly valuable.

非肌层浸润性膀胱癌每年在美国影响大约82,000人，其中约59,000例为复发病例。大多数患者在晚年被诊断出来，可能面临多次复发，这使得非手术替代方案尤为有价值。

The treatment uses the company’s proprietary RTGel® technology to deliver mitomycin directly into the bladder, offering a non-surgical alternative to repeated transurethral resections commonly required for this patient group.

该治疗利用公司的专有RTGel®技术将丝裂霉素直接递送到膀胱，为这一患者群体提供了反复经尿道切除术的非手术替代方案。

ZUSDURI combines mitomycin with a sterile hydrogel and is delivered using UroGen’s proprietary sustained-release RTGel® technology. It is specifically designed for tumour ablation and provides a non-surgical treatment option for patients who would otherwise require repeat procedures under general anaesthesia..

ZUSDURI结合了丝裂霉素和无菌水凝胶，并通过UroGen专有的缓释RTGel®技术进行递送。它专为肿瘤消融设计，为那些原本需要在全身麻醉下接受多次手术的患者提供了一种非手术治疗选择。

The approval is based on data from the Phase 3 ENVISION trial, which showed a complete response in 78% of patients after three months. Among those who responded, 79% remained event-free after 12 months.

该批准基于三期ENVISION试验的数据，数据显示78%的患者在三个月后完全缓解。在有反应的患者中，79%在12个月后仍无事件发生。

LG-IR-NMIBC is usually treated with a surgical procedure known as transurethral resection of bladder tumour (TURBT). Due to the high recurrence rate of this type of bladder cancer, patients often undergo multiple TURBT procedures over time. ZUSDURI offers an alternative to this repeated surgical intervention..

LG-IR-NMIBC 通常采用经尿道膀胱肿瘤切除术 (TURBT) 进行治疗。由于此类膀胱癌的复发率较高，患者往往会在一段时间内接受多次 TURBT 手术。ZUSDURI 为这种反复的手术干预提供了一种替代方案。

The most commonly reported side effects (≥10%) include elevated creatinine and potassium levels, urinary discomfort, reduced haemoglobin, liver enzyme changes, urinary tract infections, and blood in the urine. Serious adverse events were reported in 12% of patients, including urinary retention and urethral narrowing..

最常见的副作用（≥10%）包括肌酐和钾水平升高、尿路不适、血红蛋白减少、肝酶变化、尿路感染和血尿。严重不良事件发生在12%的患者中，包括尿潴留和尿道狭窄。

In preparation, UroGen has plans to launch a dedicated patient website and support services aimed at helping patients access the treatment. These services may include assistance with insurance coverage and financial support for eligible individuals.

为做好准备，UroGen计划推出一个专门的患者网站和支持服务，旨在帮助患者获取治疗。这些服务可能包括协助保险覆盖范围以及为符合条件的个人提供财务支持。

ZUSDURI is expected to be commercially available in the U.S. by early July 2025.

ZUSDURI 预计将于 2025 年 7 月初在美国上市。