FDA批准赛诺菲和再生元的PD-1单抗Libtayo用于治疗晚期皮肤鳞状细胞癌

2018-09-29 MedSci MedSci原创

9月29日,FDA批准赛诺菲和再生元联合开发的PD-1单抗Libtayo(cemiplimab-rwlc)用于治疗不适合进行手术或放射治疗的转移性或局部晚期的皮肤鳞状细胞癌(CSCC) 患者。Libtayo是美国第一个批准用于晚期CSCC的治疗药物。

9月29日,FDA批准赛诺菲和再生元联合开发的PD-1单抗Libtayo(cemiplimab-rwlc)用于治疗不适合进行手术或放射治疗的转移性或局部晚期的皮肤鳞状细胞癌(CSCC) 患者。Libtayo是美国第一个批准用于晚期CSCC的治疗药物。

CSCC在美国占所有皮肤癌的1/5,每年有约70万名新病例,新诊断的患者数量还在不断增加。CSCC通常在暴露在阳光或紫外线照射下的皮肤中发生。虽然大多数CSCC患者可以通过手术切除来治愈,但是少数患者的癌症会进入晚期,它们不再对局部疗法产生应答。晚期CSCC会导致出血和感染的并发症,而且它们可以转移到局部淋巴结或身体的其它组织和器官中,可能危及生命。

Libtayo是赛诺菲和再生元公司研发的全人源化抗PD-1单克隆抗体,以前称为REGN281。通过阻断PD-1信号通路,它可以帮助人体的免疫系统杀伤肿瘤细胞。它已经获得了FDA"突破性治疗"认证。

此次批准是基于中期EMPOWER-CSCC 1试验和I期研究1423的数据。EMPOWER-CSCC 1结果已经在今年6月发表在NEJM杂志上,结果显示Libtayo治疗的患者有47.5%的响应率。

Regeneron全球临床开发副总裁兼转化科学和临床肿瘤学负责人Israel Lowy表示:"我们将专注于推动Libtayo作为潜在单药或联合治疗其他癌症类型。"

该疗法也正在欧洲监管机构进行审核,用于治疗不能手术的转移性或局部晚期CSCC患者。

原始出处:


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    2018-09-29 liumin1987

    皮肤鳞状细胞癌的新的药物治疗。

    0

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