Patient, industry, and regulatory perspective on antibody-drug conjugates dose optimization.
Patient, industry, and regulatory perspective on antibody-drug conjugates dose optimization.
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患者、行业和监管机构对抗体药物偶联物剂量优化的看法。
DOI：
10.1111/cts.13759
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发表时间：
2024
期刊：
影响因子：
--
通讯作者：
Zhou,Zhu
中科院分区：
文献类型：
--
作者：
Hamed,Salaheldin;Li,Chunze;Liao,MichaelZ;Warwick,Lorna;Zhou,Zhu
抗体药物偶联物 (ADC) 代表了肿瘤药物开发中快速发展的领域。关于如何扩大 ADC 治疗窗口，防止患者接受更有效的治疗来治疗危及生命的疾病，仍然存在一个关键差距。为了最大限度地提高下一代 ADC 的安全性和有效性，必须通过整合全部证据（包括通过定量模型听取患者的观点）来优化剂量。在这里，我们总结了患者、行业和监管机构对 ADC 剂量优化的看法。
Antibody-drug conjugates (ADCs) represent a rapidly evolving area of oncology drug development. A critical gap remains regarding how we can widen ADC therapeutic windows that prevents patients from receiving more effective treatments for their life-threatening illnesses. To maximize the safety and efficacy of next-generation ADCs, it is imperative to optimize the dosages by integrating the totality of evidence, including patient perspectives via quantitative modeling. Here, we summarize the patient, industry, and regulatory perspectives on ADC dose optimization.