The U.S. Food and Drug Administration (FDA) recently announced two exciting and innovative initiatives from FDA’s Oncology Center of Excellence: Project Orbis and Real-Time Oncology Review (RTOR) Pilot Program.
Project Orbis, an initiative of the FDA Oncology Center of Excellence (OCE), will provide a framework for concurrent submission and review of oncology products between international partners. The Project’s objective is to allow patients with cancer to receive earlier access to products in other countries where there may be significant delays in regulatory submissions, regardless of whether the product has received FDA approval.
Real-Time Oncology Review
The Oncology Center of Excellence Real-Time Oncology Review (RTOR) announced a pilot program with aims to explore a more efficient review process to ensure that safe and effective treatments are available to patients as early as possible. As part of this pilot, FDA will accept an early package submission that includes complete SDTM datasets and top line efficacy tables/figures followed by a completed supplemental New Drug Application (sNDA) and supplemental Biologic License Application (sBLA). For the pilot program, multiple sNDA and sBLA submissions will be selected from each clinical division.