FDA Project Orbis and Delivery of New Oncology Drugs to Market

Are you developing an oncology drug? Project Orbis, a program coordinated by the U.S. Food and Drug Administration (FDA), allows you to register your product in several countries with concurrent submissions. Find out how to leverage Project Orbis for your product and how we can support your submission.

The FDA’s Oncology Center of Excellence (OCE) established Project Orbis in 2019, with the aim of facilitating oncology product submissions in other countries without slowing down actions in the U.S. Since then, regulatory authorities from several countries have agreed to participate in Project Orbis, including Australia, Canada, Singapore, Switzerland, Brazil, the United Kingdom, and Israel. 

Through a framework of concurrent regulatory submissions and reviews, Project Orbis aims to shorten the lead time for a drug’s possible authorization—speeding up patient access to innovative cancer treatments. 

New marketing authorization applications and new indication applications (i.e., variations) for oncology products are eligible for Project Orbis. Applications must meet the criteria for FDA priority review and qualifying criteria for the local accelerated regulatory programs from some specific participating regulatory authorities/Orbis Partner’s (POPs). Apart from the FDA, at least one more regulatory authority should be selected by the sponsor to participate. 

Based on the submission timelines proposed by the sponsor, the collaboration between the FDA and other POPs during the evaluation of the application will be established, thereby determining the applicable type of evaluation process (Type A, B, or C). In general terms, the more simultaneous marketing submissions, the closer the regulatory opinions will be issued by the FDA and other PRAs.      

From June 2019 to June 2020, Project Orbis received a total of 60 marketing application submissions, resulting in 38 international approvals. The median time-to-approval of all products in the first year was 4.2 months for FDA submissions (range 0.9–6.9, N=18) and 4.4 months for the POPs (range 1.7–6.8, N=20). For new active substances, the timeline was slightly longer, taking a median of 5.1 months for the FDA (range: 3.9–6.9, N=6) and 5.9 months for the POPs (range 3.9–6.8, N=7). Overall, these timelines are significantly shorter when compared with the standard 10-month FDA review. 

The median time gap for approvals for Type A applications between FDA and the PRAs was 1.1 months, with 90% of the approvals conducted within 2.4 months of the FDA approval date. 

Project Orbis program serves as an efficient regulatory platform ensuring marketing authorization assessment while accelerating global patient access to new oncology products. 

In line with our commitment to improving healthcare innovation, we have been closely following and analyzing Project Orbis since its inception. For companies interested in taking advantage of Project Orbis, we highly recommend: 

• Outline a roadmap early: clearly define each activity and step to ensure sufficient resources 
• Setting up your pre-submission meetings with targeted countries as early as possible 

• Assessing the impact of national regulatory and legal requirements on your plan 

Additionally, sponsors should be prepared to deal with a significant amount of information requests from regulatory authorities during the assessment procedure.   

About Alira Health

As experienced regulatory consultants, Alira Health can provide your company with full support for the preparation and submission, to Project Orbis, and—most importantly—provide guidance during the critical steps of the marketing authorization evaluation process. Together, we will deliver your drug to oncology patients around the world. 

References 

• De Claro, R Angelo et al. “Project Orbis: Global Collaborative Review Program.” Clinical cancer research: an official journal of the American Association for Cancer Research vol. 26,24 (2020): 6412-6416. doi:10.1158/1078-0432.CCR-20-3292 

 Abbreviation 

• FDA: Food and Drug Administration 
• OCE: Oncology Center of Excellence 
• POP: Participating Orbis Partner