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

Target time assessment is There are three different types of submissions depending on the timelines between the FDA and the POPs. 1. Type A: Applications should be submitted concurrently or near-concurrently (within 30 days) to the FDA and the POP. These are termed Type A Orbis (Regular Orbis) and allow for maximal collaboration during the review phase and the possibility of concurrent action with the FDA. 2. Type B: Applications submitted with a greater than 30-day delay or a regulatory action greater than 3 months of the FDA action are termed Type B Orbis (Modified Orbis) and allow the possibility of concurrent review with FDA but no concurrent action. 3. Type C: If the FDA has already taken regulatory action, a Type C Orbis (Written Report Only Orbis) allows the FDA to share their completed review documents with the POP but there is no concurrent review or action with the FDA. *See Reference 'Project Orbis Types' for a table comparing the three submission types. 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). .