Tumor-Agnostic Therapies: Translating Scientific Breakthroughs Into Global Implementation.

Since the US Food and Drug Administration's landmark 2017 approval of pembrolizumab for microsatellite instability-high tumors, nine tumor-agnostic drugs have been approved, offering unprecedented treatment options for patients with rare cancers and actionable genomic alterations.

自美国食品药品监督管理局（FDA）在2017年批准派姆单抗用于微卫星不稳定性高的肿瘤以来，已有九种肿瘤不特异性药物获得批准，为罕见癌症和可操作基因组改变的患者提供了前所未有的治疗选择。

However, this scientific breakthrough has revealed profound global implementation challenges.

然而，这一科学突破揭示了深远的全球实施挑战。

We reviewed the current landscape of tumor-agnostic drug approvals, regulatory pathways, and implementation experiences across multiple regions, including Europe, Asia-Pacific, Latin America, Africa, and the Middle East.

我们回顾了包括欧洲、亚太、拉丁美洲、非洲和中东在内的多个地区肿瘤不可知药物批准、监管途径和实施经验的当前状况。

Barriers to access were examined across regulatory, reimbursement, infrastructure, and workforce domains to inform a conceptual framework for implementation.

在监管、报销、基础设施和劳动力领域进行了访问障碍的审查，为实施构建了一个概念框架。

Access remains inconsistent even in high-resource settings, with fewer than 50% of eligible patients receiving matched therapies.

即使在资源丰富的环境中，访问仍然不一致，符合条件的患者中不到50%接受匹配治疗。

In Europe, centralized regulatory approval through the European Medicines Agency contrasts sharply with fragmented national reimbursement decisions, creating delays in access.

在欧洲，通过欧洲药品管理局的集中监管批准与分散的国家报销决策形成鲜明对比，导致了获取药物的延迟。

Asia-Pacific nations demonstrate rapid growth in tumor-agnostic approvals and drug development capacity, although significant urban-rural disparities persist.

亚太国家在肿瘤无关批准和药物开发能力方面显示出快速的增长，尽管显著的城市-农村差异仍然存在。

Latin America, Africa, and areas in the Middle East face fundamental barriers, including limited testing infrastructure, workforce shortages, and competing health care priorities.

拉丁美洲、非洲以及中东地区的部分地区面临着基本障碍，包括有限的检测基础设施、劳动力短缺以及与之竞争的医疗优先事项。

To address these challenges, we propose a four-pillar framework for equitable implementation: comprehensive biomarker testing capability, innovative clinical trial designs with decision-support systems, harmonized regulatory approval and reimbursement mechanisms, and investment in genomically competent workforce development.

为了解决这些挑战，我们提出了一个四柱框架，以实现公平实施：全面的生物标志物检测能力、具有决策支持系统的创新临床试验设计、协调一致的监管批准和报销机制，以及投资于基因组学能力劳动力发展的投资。

International initiatives including Project Orbis and cross-border trial consortia demonstrate promising models for regulatory convergence.

包括项目Orbis和跨国试验联盟在内的国际倡议展示了监管趋同的有希望的模式。

Realizing the transformative potential of tumor-agnostic therapies requires coordinated global strategies that bridge the divide between genomic innovation and geographic accessibility, ensuring all patients benefit regardless of socioeconomic status or location.

实现肿瘤无关疗法的变革潜力需要协调的全球策略，以弥合基因组创新与地理可及性之间的差距，确保所有患者无论社会经济地位或地理位置都能受益。