FDA大范围叫停PD-1/PD-L1用于血液肿瘤的临床研究

2017-09-24 佚名 医药魔方数据

在今年6月Keytruda联合来那度胺或泊马度胺治疗多发性骨髓瘤的III期临床试验(KEYNOTE-183,KEYNOTE-185)因为出现患者死亡而被暂停后,FDA近日又部分暂停(partial hold)了罗氏Tecentriq联合来那度胺(Ib)或泊马度胺(Ib/II)治疗复发或难治性多发性骨髓瘤的两项临床试验,以调查免疫检查点抑制剂与患者死亡之间的关系。

在今年6月Keytruda联合来那度胺或泊马度胺治疗多发性骨髓瘤的III期临床试验(KEYNOTE-183,KEYNOTE-185)因为出现患者死亡而被暂停后,FDA近日又部分暂停(partial hold)了罗氏Tecentriq联合来那度胺(Ib)或泊马度胺(Ib/II)治疗复发或难治性多发性骨髓瘤的两项临床试验,以调查免疫检查点抑制剂与患者死亡之间的关系。

因为是部分暂停,已经入组的患者和初步获得临床获益的患者可以继续接受Tecentriq治疗。罗氏表示会与FDA密切沟通并配合其调查。

罗氏在一份公开声明中指出,我们认为FDA正在调查所有正在进行的anti-PD1/PDL1药物联合免疫调节药物用于血液肿瘤的临床研究,以判定患者死亡事件是否是该类药物治疗多发性骨髓瘤/血液癌症时会共同面临的一个问题。

1周前,FDA刚刚暂停Opdivo用于治疗复发或难治性多发性骨髓瘤的 I期CheckMate-039和CA204142研究以及III期CheckMate-602研究。在BMS披露临床试验部分暂停几个小时后,Celgene也宣布 Imfinzi联合其他免疫和化学疗法治疗血液肿瘤的6项临床研究被FDA全部或部分暂停。

FDA在声明中指出,当局正与开展PD-1/PD-L1联合其他免疫调节剂治疗血液肿瘤的临床试验的赞助方沟通。FDA会采取适当措施来确保入组患者的权益,研究者、医生也需要明白这种在研疗法的临床风险。

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    2017-09-26 luominglian113

    学习了.谢谢分享

    0

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    2017-09-26 smartjoy
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    2017-09-25 hfuym10906

    学习了学习了学习了学习了学习了学习了...

    0

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    2017-09-24 1201eeedm13暂无昵称

    受益菲浅

    0

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    2017-09-24 清风拂面

    谢谢分享.学习了

    0

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    2017-09-24 李东泽

    是很好的学习材料.不错.以后会多学习.

    0

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