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FDA批准全新药物类别用于治疗多发性骨髓瘤 获加速批准
FDA已授予iberdomide联合达雷妥尤单抗和地塞米松用于治疗复发或难治性多发性骨髓瘤成年患者的加速批准,标志着一类全新的癌症药物CELMoD首次获批。
本文由AI根据下方引用的来源综合生成。
美国食品药品监督管理局于8月13日授予iberdomide(由百时美施贵宝以Zenbexus品牌销售)联合达雷妥尤单抗、透明质酸酶-fihj和地塞米松的加速批准,适用于已接受过至少一线包含蛋白酶体抑制剂和免疫调节剂治疗的多发性骨髓瘤成年患者。该联合疗法被称为IberDd,是全新药物类别——cereblon E3连接酶调节剂(CELMoD)的首个获批药物。
此次批准基于EXCALIBER-RRMM试验的结果,这是一项针对既往接受过一到两线治疗的复发或难治性多发性骨髓瘤成年患者的随机、多中心、开放标签研究。衡量药物疗效的关键指标——微小残留病灶(MRD)阴性完全缓解率,在接受新型IberDd联合疗法的患者中达到41%,而接受旧有DVd方案的患者中这一比例为21%,差异具有高度统计学意义。
此次审查是在FDA肿瘤卓越中心的Project Orbis框架下进行的,该计划允许多个国家的监管机构同步审查癌症药物;此次申请中,FDA与瑞士药品监管局Swissmedic共同合作。多发性骨髓瘤是一种发生于骨髓浆细胞的癌症,尽管近年来治疗方面取得进展,但该病在很大程度上仍无法治愈,这使得具有独特作用机制的新药物类别对已用尽标准治疗方案的患者尤为重要。
Key facts
- The FDA granted accelerated approval to iberdomide (Zenbexus) on August 13
- It is used in combination with daratumumab, hyaluronidase-fihj and dexamethasone
- It is the first approval for a new drug class called CELMoDs
- In trials, 41% of patients achieved MRD-negative complete response versus 21% on the older regimen
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