Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.
Office of Oncologic Diseases, U.S. Food and Drug Administration, Silver Spring, Maryland.
Clin Cancer Res. 2020 Dec 15;26(24):6412-6416. doi: 10.1158/1078-0432.CCR-20-3292. Epub 2020 Oct 9.
In 2019, the FDA Oncology Center of Excellence launched Project Orbis, a global collaborative review program to facilitate faster patient access to innovative cancer therapies across multiple countries. Project Orbis aims for concurrent submission, review, and regulatory action for high-impact clinically significant marketing applications among the participating partner countries. Current Project Orbis partners (POP) include the regulatory health authorities (RHA) of Australia, Brazil, Canada, Singapore, and Switzerland. Project Orbis leverages the existing scientific and regulatory partnerships between the various RHA under mutual confidentiality agreements. While FDA serves as the primary coordinator for application selection and review, each country remains fully independent on their final regulatory decision. In the first year of Project Orbis (June 2019 to June 2020), a total of 60 oncology marketing applications were received, representing 16 unique projects, and resulting in 38 approvals. New molecular entities, also known as new active substances, comprised 28% of the received marketing applications. The median time gap between FDA and Orbis submission dates was 0.6 months with a range of -0.8 to 9.0 months. Across the program, the median time-to-approval was similar between FDA (4.2 months, range 0.9-6.9, = 18) and the POP (4.4 months, range 1.7-6.8, = 20). Participating countries have signified a strong commitment for continuation and growth of the program. Project Orbis expansion considerations include the addition of more countries and management of more complex applications.
2019 年，美国食品药品监督管理局肿瘤卓越中心启动了“奥比斯项目”，这是一个全球性的合作审查项目，旨在促进多个国家的创新癌症疗法更快地惠及患者。“奥比斯项目”旨在实现参与伙伴国之间具有重大临床意义的高影响力营销申请的同步提交、审查和监管行动。目前的“奥比斯项目”伙伴（POP）包括澳大利亚、巴西、加拿大、新加坡和瑞士的监管卫生当局（RHA）。“奥比斯项目”利用了各 RHA 之间现有的科学和监管伙伴关系，并在相互保密协议下进行。虽然 FDA 作为申请选择和审查的主要协调者，但每个国家在最终监管决策上仍保持完全独立。在“奥比斯项目”的第一年（2019 年 6 月至 2020 年 6 月），共收到 60 份肿瘤学营销申请，涉及 16 个独特项目，最终批准了 38 个项目。新分子实体，也称为新活性物质，占收到的营销申请的 28%。FDA 和“奥比斯”提交日期之间的中位数时间差距为 0.6 个月，范围为-0.8 至 9.0 个月。在整个项目中，FDA（4.2 个月，范围 0.9-6.9， = 18）和 POP（4.4 个月，范围 1.7-6.8， = 20）的批准中位时间相似。参与国已表示强烈承诺继续和扩大该项目。“奥比斯项目”的扩展考虑因素包括增加更多的国家和管理更复杂的申请。
