The Project Orbis pathway has been developed by the US Food and Drug Administration of ORBIS.

This pathway can be used where • Project Orbis is a programme coordinated by the US Food and Drug Administration (FDA) to review and approve promising cancer treatments. • New marketing authorisation applications (MAAs) and new indication applications (variations) for oncology products are eligible for Project Orbis. • Selection of products to be included in Project Orbis is coordinated by the FDA, and initial queries received by participating regulatory health authorities are referred to the FDA. • Clinical criteria for FDA selection of applications for Project Orbis include high-impact and clinically significant applications. Project Orbis applications are generally expected to meet the criteria for FDA priority review. Qualifying criteria for FDA priority review include: the drug is intended to treat a serious condition, and if approved, would provide a significant improvement in safety or effectiveness. .

Regional regulatory initiatives can help optimize the efficient use of an agency’s resources. The following countries participate in this initiative/pathway: Australia Brazil Canada Israel Japan Singapore Switzerland United Kingdom United States

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 to 6.9, N=18) and the Project Orbis Partners (4.4 months, range 1.7 to 6.8, N=20).