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神经母细胞瘤的治疗或迎突破性进展:Nivatrotamab获得FDA“孤儿药称号”和“罕见儿科疾病称号”

2020-10-08 Allan MedSci原创

神经母细胞瘤(Neuroblastoma)是一种在特定神经组织中形成的癌症。它最常从一侧肾上腺开始,但也可以在颈部、胸部、腹部或脊髓中发展。症状包括骨痛、腹部、颈部或胸部肿块,或皮肤下无痛的蓝色肿块。

神经母细胞瘤(Neuroblastoma)是一种在特定神经组织中形成的癌症。它最常从一侧肾上腺开始,但也可以在颈部、胸部、腹部或脊髓中发展。症状包括骨痛、腹部、颈部或胸部肿块,或皮肤下无痛的蓝色肿块。

生物制药公司Y-mAbs Therapeutics今天宣布,FDA已授予其领先的双特异性抗体nivatrotamab用于治疗神经母细胞瘤的孤儿药称号(ODD)和罕见儿科疾病称号(RPDD)。

Nivatrotamab是一种人源化双特异性抗GD2抗体,目前正与Memorial Sloan Kettering癌症中心合作开展治疗复发难治GD2阳性神经母细胞瘤以及晚期骨肉瘤的I期临床试验。

Y-mAbs Therapeutics总裁Thomas Gad说:“我们对nivatrotamab的ODD感到非常满意,因为这可能会使我们在上市后获得七年市场独占权。RPDD使我们有资格在获得生物药许可证申请的批准后获得优先审查凭证(PRV)”。

 

原始出处:

https://www.firstwordpharma.com/node/1763465?tsid=4

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    2020-12-18 tamgche
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    2021-05-14 snf701207
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    2020-12-07 Isaacgong

    为神母患儿带来了新的希望啊

    0

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    2020-10-10 syscxl
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