强生(JNJ.US)获FDA批准突破性疗法 超80%患者肿瘤完全消失

智通财经
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【强生(JNJ.US)获FDA批准突破性疗法 超80%患者肿瘤完全消失】智通财经APP获悉,强生(JNJ.US)今日宣布,美国FDA已批准其创新药物Inlexzo(吉西他滨膀胱内药物释放系统[iDRS]),用于治疗对卡介苗(BCG)无应答,携带原位癌(CIS)的成人非肌层浸润性膀胱癌(NMIBC)患者,伴或不伴乳头状肿瘤。Inlexzo的批准主要基于SunRISe-1单臂、开放标签2b期临床研究的数据。结果显示,使用Inlexzo治疗的BCG无应答NMIBC患者中有82%达到完全缓解(CR),即治疗后未观察到癌症迹象(95% CI:72-90)。该高缓解率具有显著持久性,其中51%的患者维持至少一年的完全缓解。

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