强生(JNJ.US)突破性疗法获优先审评资格 超80%患者肿瘤完全消失

智通财经
Jul 18, 2025

智通财经APP获悉,今日,强生(JNJ.US)宣布,美国FDA已授予其创新膀胱内药物释放系统TAR-200新药申请(NDA)优先审评资格,用于治疗对卡介苗(BCG)无应答的高危非肌层浸润性膀胱癌(HR-NMIBC)伴原位瘤患者。根据新闻稿,TAR-200是旨在为膀胱癌治疗提供持续局部药物递送的首款膀胱内药物释放系统(iDRS)。

高危非肌层浸润性膀胱癌是一种更易复发或扩散至膀胱内层并进展为肌层浸润性膀胱癌的非侵袭性膀胱癌类型,与低危非肌层浸润性膀胱癌相比,其进展风险更高。目前,对于BCG治疗失败的非肌层浸润性膀胱癌患者,推荐进行根治性膀胱切除术,如果在进展为肌层浸润性膀胱癌之前进行手术,癌症特异性生存率超过90%。考虑到非肌层浸润性膀胱癌通常影响老年患者,许多人不愿或不适合接受根治性膀胱切除术,高复发率和进展率可能会给这些患者带来显著的疾病负担和心理困扰。

这次新药申请主要基于2b期SunRISe-1研究的数据支持。分析显示,TAR-200使82.4%的患者达到完全缓解(CR),且52.9%的患者在达到CR后维持无癌状态至少一年或更久(95% CI:72.6-89.8)。

TAR-200是一种在研的膀胱内药物释放系统,旨在实现吉西他滨在膀胱中的持续局部释放,维持局部药物暴露时间长达数周。

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