默克的Keytruda成为美国批准用于治疗非肌肉浸润性膀胱癌的抗PD-1治疗药物

2020-01-09 不详 MedSci原创

美国食品药物管理局于周三批准了默克的Keytruda(pembrolizumab),用于对卡介苗(BCG)不应答、高风险的、有或无乳头状瘤、不适合或已决定不进行膀胱切除术的非肌层浸润性膀胱癌(NMIBC)原位癌(CIS)患者。

美国食品药物管理局于周三批准了默克的Keytruda(pembrolizumab),用于对卡介苗(BCG)不应答、高风险的、有或无乳头状瘤、不适合或已决定不进行膀胱切除术的非肌层浸润性膀胱癌(NMIBC)原位癌(CIS)患者。

默克研究实验室临床研究副总裁Scot Ebbinghaus指出:"作为首个用于治疗该疾病的抗PD-1药物,Keytruda将为该类患者提供一种新的临床选择。"

KEYNOTE-057 II期临床试验中对疗效进行了评估,该试验招募了148例高危NMIBC患者,其中96例为对BCG无应答的CIS。96例患者的完全缓解率为41%,中位缓解时间为16.2个月。FDA指出,有46%的应答患者经历了至少12个月的完全反应。

Keytruda于2017年批准用于一线和二线治疗某些局部晚期或转移性尿路上皮癌。

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    2020-01-09 留走人康

    膀胱癌真怪,明明是免疫敏感性肿瘤,为什么PD-1治疗效果不好呢?难道靶点不对?将来CD47会不会有效

    0

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