FDA批准PEPAXTO(美法仑氟苯甲酰胺)用于治疗复发难治多发性骨髓瘤

2021-03-01 Allan MedSci原创

PEPAXTO是一款抗癌肽-药物偶联物(PDC),其靶向氨基肽酶并将烷基化剂迅速释放到肿瘤细胞中。

生物技术公司Oncopeptides今天宣布,美国食品药品监督管理局(FDA)已批准PEPAXTO®(美法仑氟苯甲酰胺)与地塞米松联用,用于治疗复发或难治性多发性骨髓瘤患者,这些患者先前已接受了至少四项先前疗法,包括蛋白酶体抑制剂、免疫调节剂、靶向CD38的单克隆抗体。

Oncopeptides将立即开始向全美国的医疗保健专业人员推广PEPAXTO。PEPAXTO是一款抗癌肽-药物偶联物(PDC),其靶向氨基肽酶并将烷基化剂迅速释放到肿瘤细胞中,PEPAXTO也是FDA批准的首个抗癌肽-药物偶联物。在临床前研究中,PEPAXTO在对硼替佐米和烷化剂美法仑具有抗性的骨髓瘤细胞中显示出抗骨髓瘤活性。

Oncopeptides AB的首席执行官Marty J Duvall说:“在美国,PEPAXTO的加速批准是癌肽的重要里程碑,也是我们通过创新科学为难治性血液病患者带来希望的重要一步。我们期待在第二季度从OCEAN III期研究中获得复发难治多发性骨髓瘤的主要数据”。

 

原始出处:

https://www.firstwordpharma.com/node/1804863?tsid=4

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    2021-10-14 jml2009
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    2021-05-23 feather89
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encryptionId=830c4258913, topicName=复发难治)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=02f5179, createdName=luoxiaog, createdTime=Sat Dec 11 07:30:29 CST 2021, time=2021-12-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1427497, encodeId=ad57142e49780, content=<a href='/topic/show?id=221d685172' target=_blank style='color:#2F92EE;'>#EPA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=6851, encryptionId=221d685172, topicName=EPA)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=4a9b4077760, createdName=gwc384, createdTime=Wed Mar 03 00:30:29 CST 2021, time=2021-03-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=944668, encodeId=1086944668ab, content=学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=78, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210302/5d0c146203474b24ab2bd261596b48ef/6039b04297be4ff1b79223dbc27e7a08.jpg, createdBy=b8ed5413156, createdName=ms1000000091199067, createdTime=Tue Mar 02 09:35:16 CST 2021, time=2021-03-02, status=1, ipAttribution=)]
    2021-04-03 bugit
  5. [GetPortalCommentsPageByObjectIdResponse(id=1773106, encodeId=a49f1e7310604, content=<a href='/topic/show?id=8face99717c' target=_blank style='color:#2F92EE;'>#美法仑#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=45, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=79971, encryptionId=8face99717c, topicName=美法仑)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=58de38466861, createdName=linlin2325, createdTime=Sat Dec 18 07:30:29 CST 2021, time=2021-12-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1890225, encodeId=24701890225d0, content=<a href='/topic/show?id=760c430895a' target=_blank style='color:#2F92EE;'>#多发性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=43089, encryptionId=760c430895a, topicName=多发性)], attachment=null, authenticateStatus=null, createdAvatar=, 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encryptionId=830c4258913, topicName=复发难治)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=02f5179, createdName=luoxiaog, createdTime=Sat Dec 11 07:30:29 CST 2021, time=2021-12-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1427497, encodeId=ad57142e49780, content=<a href='/topic/show?id=221d685172' target=_blank style='color:#2F92EE;'>#EPA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=6851, encryptionId=221d685172, topicName=EPA)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=4a9b4077760, createdName=gwc384, createdTime=Wed Mar 03 00:30:29 CST 2021, time=2021-03-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=944668, encodeId=1086944668ab, content=学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=78, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210302/5d0c146203474b24ab2bd261596b48ef/6039b04297be4ff1b79223dbc27e7a08.jpg, createdBy=b8ed5413156, createdName=ms1000000091199067, createdTime=Tue Mar 02 09:35:16 CST 2021, time=2021-03-02, status=1, ipAttribution=)]
    2021-07-12 ms1000000105223506

    学习了,真是一篇好文章……

    0

  6. 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  7. 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topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210302/5d0c146203474b24ab2bd261596b48ef/6039b04297be4ff1b79223dbc27e7a08.jpg, createdBy=b8ed5413156, createdName=ms1000000091199067, createdTime=Tue Mar 02 09:35:16 CST 2021, time=2021-03-02, status=1, ipAttribution=)]
    2021-04-03 446993560

    学习了

    0

  8. 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    2021-03-03 gwc384
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    2021-03-02 ms1000000091199067

    学习了

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