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急性髓细胞白血病的治疗药物或将再添新成员：MB-102（CD123 CAR T）获FDA孤儿药物认定

2019-07-25 Allan MedSci原创

MB-102急性髓细胞白血病CD123CART
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Mustang Bio是一家临床阶段的生物制药公司，专注开发治疗肿瘤的细胞和基因疗法，今天宣布美国FDA已授予MB-102（CD123 CAR T）孤儿药物认定，用于治疗急性髓性白血病（AML）。

Mustang Bio是一家临床阶段的生物制药公司，专注开发治疗肿瘤的细胞和基因疗法，今天宣布美国FDA已授予MB-102（CD123 CAR T）孤儿药物认定，用于治疗急性髓性白血病（AML）。FDA此前还授予MB-102（CD123 CAR T）孤儿药物认定，用于治疗急性浆细胞样树突状细胞肿瘤（BPDCN）。

Mustang Bio总裁兼首席执行官Manuel Litchman说：“我们很高兴MB-102在两种适应症（AML和BPDCN）中获得了孤儿药物认定。MB-102有可能成为这些患者的重要疗法，并可能解决多个医疗需求。我们期望开展一项多中心的I/II期临床试验，以评估MB-102治疗AML、BPDCN和高危骨髓增生异常综合征患者的有效性和安全性”。


原始出处：

http://www.firstwordpharma.com/node/1654853#axzz5ug3cIKrI

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    2020-03-16 shenxlcyp

    #髓细胞白血病#

    0

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    2019-11-07 智慧医人

    #孤儿药物#

    0

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    2020-05-12 周虎

    #治疗药物#

    0

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    2019-07-27 chengjn

    #髓细胞#

    0

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    2019-07-27 若水129

    #孤儿药物认定#

    0

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MB-102（CD123 CAR T）获得FDA孤儿药物指定用于治疗浆细胞样树突状细胞肿瘤

Mustang Bio是一家专注于开发基于专有嵌合抗原受体工程T细胞（CAR T）技术的新型免疫疗法公司，近日宣布美国食品和药物管理局（FDA）已批准MB-102（CD123 CAR T）获得孤儿药物指定用于治疗浆细胞样树突状细胞肿瘤（BPDCN），BPDCN是一种罕见且无法治愈的血癌，中位生存期不到18个月，目前尚无标准的疗法。