Johnson & Johnson has received approval from the United States Food and Drug Administration (FDA) for INLEXZO™ (gemcitabine intravesical system), a new treatment for adults with non-muscle invasive bladder cancer (NMIBC) that has not responded to Bacillus Calmette-Guérin (BCG) therapy.

强生公司已获得美国食品药品监督管理局（FDA）批准，推出INLEXZO™（吉西他滨膀胱内给药系统），这是一种用于治疗对卡介苗（BCG）疗法无反应的非肌层浸润性膀胱癌（NMIBC）成年患者的新疗法。

INLEXZO™, previously known as TAR-200, is the first intravesical drug-releasing system (iDRS) to provide extended local delivery of gemcitabine directly into the bladder. It is designed to remain in place for three weeks per treatment cycle, for up to 14 cycles. The device is inserted by a healthcare professional in an outpatient setting within a few minutes, without the need for general anaesthesia or extended monitoring..

INLEXZO™，以前称为TAR-200，是首个提供延长局部给药的膀胱内药物释放系统（iDRS），可直接将吉西他滨递送至膀胱。该系统每个治疗周期可保持三周在位，最长可用于14个周期。该装置由医疗专业人员在门诊环境中几分钟内放置，无需全身麻醉或长时间监测。

INLEXZO™ is intended for patients seeking bladder-preserving treatment. It has been granted Breakthrough Therapy Designation, Real-Time Oncology Review and Priority Review by the FDA, reflecting its potential to address an unmet medical need.

INLEXZO™ 适用于寻求保留膀胱治疗的患者。它已获得 FDA 授予的突破性疗法认定、实时肿瘤审评和优先审评，反映了其解决未满足医疗需求的潜力。

Non-muscle invasive bladder cancer represents a significant portion of bladder cancer cases and often affects older adults. While BCG remains the standard treatment, many patients eventually become unresponsive. Radical cystectomy, the removal of the bladder, is currently recommended in such cases, but it carries high risks and impacts quality of life..

非肌层浸润性膀胱癌占膀胱癌病例的很大一部分，且常影响老年人。虽然卡介苗（BCG）仍是标准治疗，但许多患者最终会变得无应答。根治性膀胱切除术（即膀胱切除）目前在此类情况下被推荐，但它具有高风险并会影响生活质量。

The therapy also offers an option for patients unwilling or unable to undergo bladder removal surgery.

该疗法还为不愿或无法接受膀胱切除手术的患者提供了一种选择。

The approval is based on findings from the Phase 2b SunRISe-1 trial (NCT04640623). Results showed that 82 per cent of patients achieved a complete response, meaning no signs of cancer were detected after treatment. Among these patients, 51 per cent maintained their response for at least one year.

该批准基于 2b 期 SunRISe-1 试验 (NCT04640623) 的研究结果。结果显示，82% 的患者达到了完全缓解，这意味着治疗后未检测到癌症迹象。其中，51% 的患者至少一年保持了这种缓解效果。

The most commonly reported side effects included urinary frequency, urinary tract infections, painful urination, urgency, bladder irritation, blood in urine, and certain laboratory abnormalities such as changes in kidney and liver function markers.

最常见的副作用包括尿频、尿路感染、排尿疼痛、尿急、膀胱刺激、血尿以及某些实验室指标异常，如肾功能和肝功能指标的变化。

With the FDA’s approval, Johnson & Johnson will provide patient support through its J&J withMe programme, offering cost support, dedicated care navigation and educational resources.

通过FDA的批准，Johnson & Johnson公司将通过其J&J withMe项目提供患者支持，该项目将提供费用支持、专门的护理导航和教育资源。