FDA’s New Initiatives: Project Orbis and Real-Time Oncology Review

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

On September 17, 2019 FDA announced Project Orbis, an initiative of the FDA Oncology Center of Excellence (OCE), to 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.

According to the press release, pivotal clinical trials in oncology are commonly conducted internationally and these global trials are increasingly important for investigating the safety and effectiveness of cancer drugs for approval in the United States. Future drug development may benefit by establishing a greater uniformity of new global standards of treatment, leading to the optimal design of these important trials. For pharmaceutical sponsors, this will save having to prepare a separate submission dossier for each region/country in the future.

FDA, Australian Therapeutic Goods Administration (TGA) and Health Canada (HC) are the health agencies involved in Project Orbis so far. The future may see other health authorities join in this initiative. This program will provide for simultaneous approval decisions in all three participating countries. This is an excellent opportunity for patients in these countries to have immediate access to the same urgently needed products. Essentially, one regulatory submission can now yield three approvals. One caveat is each country will have their own format and content for drug labeling.

Click here for more information on Project Orbis.

Real-Time Oncology Review

On September 12, 2019 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.

Submissions likely to be considered for the RTOR pilot should meet the following criteria:

  • Drugs likely to demonstrate substantial improvements over available therapy, which may include drugs previously granted Breakthrough Therapy Designation for the same or other indications
  • Straight forward study designs, as determined by the review division and the OCE
  • Studies conducted exclusively outside the United States and neoadjuvant and prevention studies will be excluded
  • Endpoints that can be easily interpreted (for example, overall survival in a randomized trial)
  • Supplements with CMC formulation changes will be excluded, as may be complex programs


Sponsors whose submission meets the criteria may apply for the RTOR pilot by notifying their Division Project Manager. The pilot timeline is expected to decrease time to approval but is open-ended at this point.

Please click here for more information on RTOR. 

Synchrogenix, A Certara company accelerates the regulatory submissions of medical innovations worldwide through customized regulatory solutions, including strategy, communications, operations and technology. Click here to contact our regulatory services experts with any questions you may have about these initiatives or to find out how we can help your company achieve global submission success.

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