Snapshot

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. .

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

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 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).