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FDA接受了赛诺菲的申请,要求批准isatuximab用于复发难治多发性骨髓瘤患者

2019-07-11 Allan MedSci原创

赛诺菲公司近日宣布,FDA接受了isatuximab治疗复发难治多发性骨髓瘤的申请。预计FDA将于2020年4月30日前就CD38受体抑制剂isatuximab的批准做出最终决定。

赛诺菲公司近日宣布,FDA接受了isatuximab治疗复发难治多发性骨髓瘤的申请。预计FDA将于2020430日前就CD38受体抑制剂isatuximab的批准做出最终决定。

赛诺菲表示,该申请是基于IIIICARIA-MM试验的数据。该研究结果于上个月在美国临床肿瘤学会(ASCO)年会上发表,最近又在欧洲血液学协会(EHA)大会上公布。结果显示,isatuximabCelgenePomalystpomalidomide)和地塞米松联合使用,显著延长了复发难治多发性骨髓瘤患者的无进展生存期(PFS)。赛诺菲指出,isatuximab已被FDA和欧洲药品管理局(EMA)授予孤儿药认定用于治疗复发难治性多发性骨髓瘤。


原始出处:

http://www.firstwordpharma.com/node/1652198#axzz5tMRLVCBr

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    2020-05-23 jml2009
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    2020-06-19 snf701207
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    2019-07-15 1ddf0692m34(暂无匿称)

    学习了,谢谢分享

    0

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