FDA批准DANYELZA(naxitamab-gqgk)治疗神经母细胞瘤

2020-11-26 Allan MedSci原创

DANYELZA(naxitamab-gqgk)与粒细胞巨噬细胞集落刺激因子(GM-CSF)联用用于治疗1岁及以上的骨复发或难治性高危神经母细胞瘤患者。

生物制药公司Y-mAbs Therapeutics今天宣布,美国食品药品监督管理局(FDA)已批准DANYELZA(naxitamab-gqgk)与粒细胞巨噬细胞集落刺激因子(GM-CSF)联用用于治疗1岁及以上的骨复发或难治性高危神经母细胞瘤患者。DANYELZA是一种靶向神经节苷脂GD2的人源化单克隆抗体,该神经节苷脂GD2在各种神经外胚层衍生的肿瘤和肉瘤中高度表达。在门诊患者中,DANYELZA一周给药3次,每四周重复一次治疗。该产品已获得FDA的孤儿药称号、突破性疗法称号和罕见儿科疾病称号。

Y-mAbs Therapeutics董事长兼总裁Thomas Gad说:“对于患有难治性/复发性高危神经母细胞瘤的儿童来说,今天是重要的一天”。

神经母细胞瘤(Neuroblastoma)是一种在神经细胞中形成的癌症。它往往始于肾上腺(adrenal glands);此外,它或许也可始于脊椎周围的神经组织,并在颈部、胸腔、腹腔或脊椎处形成包块(masses)。神经母细胞瘤是婴儿群体里最常见的癌症,也在儿童最常见癌症中排第三。90%的神经母细胞瘤案例都是在五岁及以下儿童中确诊的。

 

原始出处:

https://www.firstwordpharma.com/node/1777847?tsid=4

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    2021-03-28 snf701207
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    2020-12-11 bugit
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