FDA批准UroGen的Zusduri作为首个复发性膀胱癌药物-动脉网

FDA Approves UroGen's Zusduri As First Drug For Recurrent Bladder Cancer

benzinga 等信源发布 2025-06-13 10:53

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The U.S. Food and Drug Administration (FDA) on Thursday approved

美国食品药品监督管理局 (FDA) 于周四批准

UroGen Pharma Ltd.’s

UroGen制药有限公司

URGN

紧急

Zusduri, the first and only FDA-approved medication for adults with recurrent low-grade intermediate-risk non-muscle invasive

Zusduri，首个且唯一获得FDA批准用于治疗复发性低级别中危非肌层浸润性膀胱癌的成人药物

bladder cancer (LG-IR-NMIBC)

膀胱癌（LG-IR-NMIBC）

。

Zusduri consists of mitomycin and sterile hydrogel, using UroGen’s proprietary sustained-release

Zusduri 由丝裂霉素和无菌水凝胶组成，采用 UroGen 专有的缓释技术。

RTGel

technology. Zusduri has been designed to treat

技术。Zusduri 旨在治疗

potent tumor ablation

有效的肿瘤消融

。

The FDA approval is based on the results from the Phase 3 ENVISION trial, which demonstrated that Zusduri delivers 78% complete response (CR) for patients at 3 months, and of those patients, 79% remained event-free 12 months later.

FDA的批准是基于ENVISION 3期试验的结果，该试验表明，Zusduri在3个月时为患者带来了78%的完全缓解率（CR），在这些患者中，79%在12个月后仍然无事件发生。

Also Read:

另请阅读：

UroGen Pharma Stock Receives Downgrade As Analyst Cites FDA Panel Setback For Key Bladder Cancer Drug

由于分析师引用了关键膀胱癌药物在FDA专家小组的挫折，UroGen Pharma股票被降级。

The existing standard of care for LG-IR-NMIBC is a surgical procedure typically performed under general anesthesia called transurethral resection of bladder tumor (TURBT). Due to high recurrence rates of LG-IR-NMIBC, repeat TURBTs may be necessary.

低级别非肌层浸润性膀胱癌（LG-IR-NMIBC）的现有护理标准是一种通常在全身麻醉下进行的手术，称为经尿道膀胱肿瘤切除术（TURBT）。由于LG-IR-NMIBC的高复发率，可能需要重复进行TURBT。

Zusduri is expected to be available in the U.S. on or around July 1, 2025, for adults with recurrent LG-IR-NMIBC.

Zusduri 预计将于 2025 年 7 月 1 日左右在美国上市，适用于复发性 LG-IR-NMIBC 成人患者。

In May, the FDA’s Oncologic Drugs Advisory Committee voted against the benefit/risk of UGN-102 (mitomycin)

今年五月，FDA的肿瘤药物咨询委员会投票反对UGN-102（丝裂霉素）的益处/风险。

for an intravesical solution

用于膀胱内溶液

。

The committee voted four yes to five no that the benefit/risk of UGN-102 for intravesical solution was favorable for recurrent LG-IR-NMIBC.

委员会以四票赞成对五票反对投票认为，UGN-102膀胱内溶液对复发性LG-IR-NMIBC的益处/风险是有利的。

The vote comes after the committee reviewed clinical data supporting the efficacy and safety of UGN-102, including the results from the Phase 3 ENVISION study.

该投票是在委员会审查了支持 UGN-102 疗效和安全性的临床数据之后进行的，其中包括 3 期 ENVISION 研究的结果。

In April, UroGen Pharma highlighted a duration of response of nearly four years from a long-term follow-up study with Jelmyto (mitomycin)

今年4月，UroGen Pharma强调了一项使用Jelmyto（丝裂霉素）进行的长期随访研究中接近四年的反应持续时间。

for pyelocalyceal solution

用于肾盂肾盏溶液

。

The FDA approved Jelmyto in 2020 for low-grade upper tract urothelial cancer (LG-UTUC) in adults.

2020年，FDA批准了Jelmyto用于治疗成人低级别上尿路上皮癌（LG-UTUC）。

Among patients from the OLYMPUS trial who achieved a complete response after primary chemoablation with Jelmyto (n = 41), the median duration of response was 47.8 months, regardless of whether their cancer was new onset or recurrent (median follow-up, 28.1 months).

在OLYMPUS试验中，接受Jelmyto初级化疗后达到完全缓解的患者（n = 41）中，无论其癌症是新发还是复发，缓解的中位持续时间为47.8个月（中位随访时间为28.1个月）。

Price Action:

价格行为:

URGN stock is up 9.61% at $12.15 at the last check on Friday.

URGN股票在上周五的最后一次检查中上涨了9.61%，达到12.15美元。

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CG Oncology’s Bladder Cancer Drug Impresses Investors – Here’s Why

CG Oncology的膀胱癌药物令投资者印象深刻——这是原因

Photo by Aunt Spray via Shutterstock

照片由Aunt Spray通过Shutterstock提供