FDA优先审评多肽-药物偶联物(PDC)Melflufen治疗难治性多发性骨髓瘤的申请

2020-08-31 Allan MedSci原创

Melflufen对骨髓瘤细胞株表现出细胞毒活性,且该细胞株对包括烷基化剂在内的其他治疗有抵抗力,并且在临床前研究中还显示出Melflufen对DNA修复和血管生成具有抑制作用。

Oncopeptide今日宣布,美国食品药品监督管理局(FDA)已对Melflufen的新药申请进行了优先审查,Melflufen(INN melphalan flufenamide)预计与地塞米松联用治疗对蛋白酶体抑制剂或免疫调节剂或抗CD-38单克隆抗体耐药的多发性骨髓瘤患者(即三级难治性多发性骨髓瘤患者)。这项决定是基于关键性II期研究HORIZON的结果,该研究评估了静脉注射Melflufen与地塞米松联用治疗复发性难治性多发性骨髓瘤(RR MM)患者的有效性和安全性。

Oncopeptides首席执行官Marty J Duvall表示:“这是令人振奋的消息,是Melflufen治疗多发性骨髓瘤患者的重要一步”。

Melflufen(INN melphalan flufenamide)是首创的多肽-药物偶联物(PDC),其能够靶向氨基肽酶并将烷化剂迅速释放到肿瘤细胞中。Melflufen由于其高亲脂性而被骨髓瘤细胞迅速吸收,并立即被肽酶水解,释放出被包裹的亲水性烷化剂负载物。氨基肽酶在肿瘤细胞中过表达,在晚期癌症和高突变负担的肿瘤中更为明显。Melflufen对骨髓瘤细胞株表现出细胞毒活性,且该细胞株对包括烷基化剂在内的其他治疗有抵抗力,并且在临床前研究中还显示出Melflufen对DNA修复和血管生成具有抑制作用。在关键的2期HORIZON研究中,Melflufen+地塞米松治疗复发性难治性多发性骨髓瘤患者的血液学AE和非血液学AE发生率低,显示出令人鼓舞的疗效和临床上可控的安全性。

 

原始出处:

https://www.firstwordpharma.com/node/1753271?tsid=4

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    2020-11-24 chenlianhui

    #pDC#

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    2020-09-10 jml2009

    #多发性#

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    2020-09-26 xzw121

    #Melflufen#

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    2020-09-02 freve

    #难治性#

    0

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    2020-09-02 fusion

    #多肽#

    0

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