Project Orbis – A framework for concurrent submission and review of oncology products

U.S. Food and Drug Administration, March 4, 2023

Project Orbis, initiated by the FDA Oncology Center of Excellence (OCE) in May 2019, aims to facilitate concurrent submission and review of oncology products among international partners. The collaboration among global regulators under Project Orbis enables patients with cancer to access treatments earlier in countries where regulatory delays are significant, regardless of FDA approval status. This framework is particularly beneficial for oncology drug development as pivotal clinical trials are often conducted globally, emphasizing the importance of establishing consistent global standards for effective trial design.

Since its establishment, Project Orbis has processed numerous oncology marketing applications and successfully approved several oncology drugs for patients worldwide. By enhancing international cooperation and streamlining the review process, Project Orbis has played a pivotal role in accelerating patient access to innovative cancer therapies. The success of Project Orbis has been attributed to the collaboration with international regulatory counterparts such as Australia, Canada, and other countries that have joined as Project Orbis Partners (POP) to enhance the efficiency of oncology product reviews.

The core team behind Project Orbis comprises dedicated professionals like R. Angelo de Claro, Dianne Spillman, Lauren Tesh Hotaki, Yinghua Wang, and Tina MacAulay, each bringing unique expertise and experience to drive the initiative forward. These team members play integral roles in managing applications, facilitating international communication, and overseeing the review process with foreign regulatory counterparts. As Project Orbis continues to evolve and expand its reach, the framework is expected to further streamline oncology product reviews and promote faster access to life-saving therapies for patients around the globe.

To read more about Project Orbis, visit the FDA site.