In this article, published in the April edition of Pharmafocus, our Senior Consultant and Project Orbis lead Claudia Reichle provides background and practical information on the FDA driven initiative Project Orbis.

At the end of 2020, the FDA Oncology Center of Excellence (OCE) published summary data for the first full year of Project Orbis. From June 2019 to June 2020, a total of 60 oncology marketing applications were received, representing 16 unique projects, and resulting in 38 approvals. New active substances comprised 28% of the received marketing applications.

In 2019, the OCE launched Project Orbis, a framework for near-concurrent submission and review of oncology products across multiple countries. This leverage of the regulatory partnerships between international agencies provides a faster patient access to innovative cancer therapies with a high medical need across multiple countries. So far, Australia, Canada, the UK, Singapore, Switzerland, and Brazil are involved.

Project Orbis applications must meet the criteria for FDA priority review. Qualifying criteria for review includes that the drug is intended to treat a serious condition and if approved, would provide a significant improvement in safety or effectiveness. Project Orbis submissions should also meet the qualifying criteria for the local accelerated regulatory programs.

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

  • Type A (Regular Orbis): Submissions are concurrently or near-concurrently (within 30 days) to FDA and POP and allow for maximal 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 FDA action, with the possibility of concurrent review with FDA but no concurrent action
  • Type C (Written Report Only Orbis): FDA has already taken regulatory action, allowing FDA to share their completed review documents with POP but without concurrent review or action with FDA.

Read More

To learn more about how we can support you if you are selected by the FDA to take part in the Project Orbis initiative, contact Claudia and her team today.

The Author

Claudia Reichle

Senior Consultant


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