In 2019, the FDA Oncology Center of Excellence (OCE) launched Project Orbis, a framework for near-concurrent submission and review of high-impact oncology products across multiple countries. This approach may give earlier access to new innovative therapies to patients with cancer globally. The three major factors allowing national decisions to be expedited through Project Orbis are, the initial FDA review, access to the same data, and the opportunity to interact with the different assessment teams.

Introduction to Project Orbis

The FDA is responsible for the selection of applications. Once an oncology project achieves prominent results from the registrational clinical trials, either the FDA or the US sponsor can propose an application.

The countries that are currently available as Project Orbis Partners are:

  • Australian Therapeutics Goods Administration (TGA)
  • Brazil's National Health Surveillance Agency (ANVISA)
  • Health Canada (HC)
  • Israel Ministry of Health (MOH) Pharmaceutical Administration
  • Singapore Health Sciences Authority (HSA)
  • Switzerland Swissmedic
  • United Kingdom Medicines and Healthcare Products Regulatory Agency (UK MHRA)

New marketing authorisation applications (MAAs) and new indication applications (variations) for oncology products are eligible for Project Orbis. The FDA review team can recommend an application for Project Orbis based on a combination of breakthrough designation, impressive results, and unmet need.

The applications are generally expected to meet the criteria for FDA priority review which include that the drug is intended to treat a serious condition and if approved, would provide a significant improvement in safety or effectiveness.

The application submission must at a minimum include the FDA plus one additional regulatory health authority. Submission to all interested Project Orbis Partners is encouraged; however, the final decision remains with the sponsor. FDA sends the proposal to the regulatory agencies to confirm interest and availability for participation.

The different types of Project Orbis

There are several types of Project Orbis submissions which are dependent on the timelines between the FDA and Project Orbis Partners.

  • Type A (Regular Orbis): Applications are submitted within 30 days to FDA and the Project Orbis Partners. This allows maximum collaboration during the review phase and the possibility of concurrent action with FDA.
  • Type B (Modified Orbis): Applications are submitted with a >30-day delay or a regulatory action >3 months of the regulatory action taken by the FDA, with the possibility of concurrent or overlapping review.
  • Type C (Written Report Only Orbis): FDA has already taken regulatory action and the completed review documents are shared with the Project Orbis Partners for evaluation and independent decisions.

During its first year, 70% of Project Orbis applications were Type A. Since Type A and B Orbis applications allow more extended collaboration, it is generally expected that the sponsor submits a 'global dossier' to the Project Orbis Partners, i.e., the same data set for Modules 2-5 (noting country-specific aspects) as submitted to the FDA. Any differences between the submissions should be clearly indicated in the application.

An additional requirement for Type A or B Orbis submissions is the use of a multidisciplinary review document, the Assessment Aid. The Assessment Aid serves as the primary review document for FDA and is a core document for the joint discussions. This means that instead of other countries rewriting the report, they can cross reference to the FDA review. To further reduce duplication, the agencies’ information requests are shared with all the partners for comments and review before it’s sent to the sponsor.

Project Orbis is a highly coordinated review collaboration amongst its partners. However, each participating authority remains fully independent regarding the regulatory decision-making for every application under their jurisdiction. This may result in differences in the approval or rejection of marketing authorization, the content of the labelling, the wording of the indications or the country-specific post-market surveillance requirements.

How to prepare for Project Orbis

Parallel regulatory reviews by multiple independent agencies may sound very resource intensive but the real-time collaboration and use of a common platform can in fact reduce the resources required by both the participating agencies and the applicants. The use of a common dossier and sharing all questions and responses between the partners has demonstrated a positive impact on the overall evaluation timelines.

The most evident benefits with this type of joint forces are:

  • Less duplication.
  • Consolidated questions across the regulatory agencies which generally means a reduced number of questions.
  • Global access to multiple markets through a simultaneous evaluation process.
  • Shortened time to regulatory approval.

Although Project Orbis represents a major milestone in regulatory collaboration, it does place some serious strains on the sponsor navigating the process.

There are some overarching demands brought on by a Project Orbis submission:

  • Having the capacity and capability for such large-scale project.
  • The unique requirements of individual participating countries.
  • The time crunch - shorter timelines and multiple parallel agency interactions.
  • High-level project management to coordinate actions on at every stage

Dealing with the different authorities simultaneously requires a solid strategy throughout the process as well as a fast turnaround to get a favourable result. Having the workforce, the project management, and the regulatory knowledge could make the difference in fulfilling the requirements in given timelines.

Is your product a potential Project Orbis candidate?
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