产业新闻 | FDA授予百时美施贵宝PD-1疗法组合优先审评资格；创新帕金森病免疫疗法积极试验结果公布

药明康德2025-12-12

FDA授予百时美施贵宝PD-1疗法组合优先审评资格百时美施贵宝（Bristol Myers Squibb）今日宣布，美国FDA已受理Opdivo（nivolumab）的补充生物制品许可申请（sBLA），用于与多柔比星、长春花碱和达卡巴嗪（AVD方案）联合，治疗既往未接受治疗的III期或IV期经典型霍奇金淋巴瘤（cHL）成人及儿童患者（年龄≥12岁）。FDA授予该申请优先审评资格，并将PDUFA日期...

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Squibb）今日宣布，美国FDA已受理Opdivo（nivolumab）的补充生物制品许可申请（sBLA），用于与多柔比星、长春花碱和达卡巴嗪（AVD方案）联合，治疗既往未接受治疗的III期或IV期经典型霍奇金淋巴瘤（cHL）成人及儿童患者（年龄≥12岁）。FDA授予该申请优先审评资格，并将PDUFA日期确定为2026年4月8日。Opdivo是一种PD-1免疫检查点抑制剂，旨在帮助恢复抗肿瘤免疫反应，利用人体自身的免疫系统来对抗癌症。此次FDA受理及优先审评的决定，主要基于3期SWOG S1826（CA2098UT）研究的积极结果。之前公布的试验结果显示，与活性对照组药物相较，Opdivo组合显著降低III或IV期经典型霍奇金淋巴瘤新确诊成人与儿童患者的癌症进展或死亡风险达52%。有94%的Opdivo组合组患者在一年内仍然存活且没有发生病情进展，而对照组的这一比例为86%（单侧p值=0.0005）。创新帕金森病免疫疗法积极试验结果公布AC Immune今日宣布，其专有抗α-突触核蛋白（a-syn）免疫疗法ACI-7104.056在早期帕金森病（PD）患者中开展的2期VacSYn试验取得积极的中期安全性和疗效结果。根据新闻稿，这是首次显示通过主动免疫治疗方式靶向a-syn相关病理机制，有望减缓帕金森病的疾病进展。试验结果显示，该疗法达成预设免疫原性终点，受试者应答率达到100%，同时在药效学作用、靶点占据以及多项临床评估指标上均达到研究设定的目标。多项疾病相关生物标志物结果包括脑脊液中a-syn及神经丝轻链蛋白（NfL）水平的变化，显示患者的PD病理可能趋于稳定。而患者血浆中胶质纤维酸性蛋白（GFAP）以及多巴胺转运体（DaT）SPECT成像结果亦呈现出该疗法具有疾病修饰作用。此外，运动障碍协会统一帕金森病评定量表（MDS-UPDRS）第三部分总分的变化同样提示患者的病情在向稳定方向发展。ACI-7104.056在本次中期分析中亦展现出明确且良好的安全性特征，未发现具有临床意义的安全问题。参考资料：[1] AC Immune Positive Interim Phase 2 Data on ACI-7104.056 Support Potential Slowing of Progression of Parkinson’s Disease. Retrieved December 11, 2025 from https://www.globenewswire.com/news-release/2025/12/11/3203753/0/en/AC-Immune-Positive-Interim-Phase-2-Data-on-ACI-7104-056-Support-Potential-Slowing-of-Progression-of-Parkinson-s-Disease.html[2] U.S. Food and Drug Administration (FDA) Grants Priority Review to Bristol Myers Squibb's Application for Opdivo® (nivolumab) Plus Chemotherapy Combination for Classical Hodgkin Lymphoma. 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