NMPA批准BYVASDA(贝伐单抗生物仿制药)治疗复发性胶质母细胞瘤

2020-12-31 Allan MedSci原创

BYVASDA®(贝伐单抗生物仿制药)已获得中国国家药品监督管理局(NMPA)的正式批准,用于治疗复发性胶质母细胞瘤(GBM,最常见的恶性原发性脑肿瘤)。

生物制药公司Innovent Biologics近日宣布,BYVASDA®(贝伐单抗生物仿制药)已获得中国国家药品监督管理局(NMPA)的正式批准,用于治疗复发性胶质母细胞瘤(GBM,最常见的恶性原发性脑肿瘤) ,这是BYVASDA®在中国获得的第三个适应症。

BYVASDA®于2020年6月17日首次获得中国国家药品监督管理局(NMPA)批准。BYVASDA®先前获得批准的适应症包括晚期非小细胞肺癌和转移性结直肠癌

近年来,中国的癌症负担一直在不断增加。根据世界卫生组织(WHO)国际癌症研究机构的报道,2018年中国新诊断癌症患者为428.5万人,癌症死亡286.5万人。在恶性肿瘤中,胶质母细胞瘤是最常见和侵袭性脑恶性肿瘤,其特点是高发病率、高复发率、高死亡率和低治愈率。当前胶质母细胞瘤的主要治疗方案包括手术切除、放疗和化学疗法。中位生存时间仅为12到15个月,在过去十年中没有明显变化。因此,胶质母细胞瘤患者迫切需要更多新的治疗方法。

 

原始出处:

https://www.firstwordpharma.com/node/1786842?tsid=4

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    2021-01-06 okhuali
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  5. 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createdTime=Sat Jan 02 10:54:51 CST 2021, time=2021-01-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=912653, encodeId=4d1c912653cb, content=BYVASDA,仿制药都来了, beContent=null, objectType=article, channel=null, level=null, likeNumber=80, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=/v1.0.0/img/user_icon.png, createdBy=a37a1710612, createdName=oo902, createdTime=Thu Dec 31 20:08:02 CST 2020, time=2020-12-31, status=1, ipAttribution=)]
    2021-01-02 drwjr
  6. 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  7. 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    2020-12-31 oo902

    BYVASDA,仿制药都来了

    0

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复发性胶质母细胞瘤成年患者每周口服 80 mg 单剂量 Selinexor 可诱导临床缓解,获得相对较高的 6 个月无进展生存率

Front Oncol:替莫唑胺联合阿帕替尼治疗复发性胶质母细胞瘤的疗效和安全性

研究表明,阿帕替尼加替莫唑胺是复发性胶质母细胞瘤有效的挽救方案,且毒性可控,同时不降低后续贝伐单抗治疗的敏感性。

Clin Cancer Res:口服Selinexor治疗复发性胶质母细胞瘤

每周一剂塞利尼索 (selinexor) 可诱导复发性胶质母细胞瘤成人患者获得缓解

Radiology:这一影像学技术,可陪伴胶质母细胞瘤患者共同前进!

胶质母细胞瘤的典型特征是血管内皮生长因子介导的血管生成,因此临床上对该蛋白的靶向治疗产生了极大兴趣。