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AbbVie的BCL-2抑制剂VENCLEXTA获得加拿大批准与利妥昔单抗联合治疗慢性淋巴细胞白血病患者

2018-09-26 MedSci MedSci原创

AbbVie今天宣布获得加拿大卫生部批准将VENCLEXTA(venetoclax)与利妥昔单抗联合用药用于先前已接受过至少一次治疗的慢性淋巴细胞白血病(CLL)的成年患者。

AbbVie今天宣布获得加拿大卫生部批准将VENCLEXTA(venetoclax)与利妥昔单抗联合用药用于先前已接受过至少一次治疗的慢性淋巴细胞白血病(CLL)的成年患者。

该批准是基于MURANO 3期临床试验数据,该数据显示VENCLEXTA与利妥昔单抗联合治疗复发/难治性(R / R)CLL患者的无进展生存期(PFS,无疾病进展或死亡的治疗时间)显着改善。与苯达莫司汀联合利妥昔单抗相比,疾病进展或死亡率降低了81%。接受VENCLEXTA/利妥昔单抗治疗患者的总有效率(ORR)为92%,接受苯达莫司汀/利妥昔单抗治疗的患者ORR为72%。

加拿大淋巴瘤科学顾问Elizabeth Lye说:"我们对VENCLEXTA与利妥昔单抗联合用于治疗慢性淋巴细胞白血病的结果感到高兴。由于该疾病的高复发率,必须为患者提供更有效的治疗选择。"

Abbvie Canada总经理StéphaneLassignardie说:"VENCLEXTA加利妥昔单抗是治疗CLL的第一个不含化疗的组合,可将患者生命延长至24个月。这项批准将为加拿大CLL患者带来急需的治疗选择。"

Venclexta是美国FDA批准的首个B细胞淋巴瘤因子-2(BCL-2)抑制剂,之前FDA已授予其突破性药物认定、优先审查资格、加速审批资格。该药是一种口服的B细胞淋巴瘤因子-2(BCL-2)抑制剂,BCL-2在细胞凋亡(程序性细胞死亡)中发挥重要作用,可阻止一些细胞(包括淋巴细胞)的凋亡,并且在某些类型癌症中过度表达,与耐药性的形成相关。venetoclax旨在选择性抑制BCL-2的功能,恢复细胞的通讯系统,让癌细胞自我毁灭,达到治疗肿瘤的目的。

原始出处:

http://www.firstwordpharma.com/node/1593282?tsid=4#axzz5S5gDx46W

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    2019-06-28 jklm09
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  5. 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  6. 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  7. 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