Project Orbis is an initiative of the FDA Oncology Center of Excellence which provides a framework for concurrent submission and review of oncology products among international partners.

In September 2019, in conjunction with decisions by Therapeutic Goods Administration in Australia and Health Canada, the FDA granted accelerated approval to Lenvima (lenvatinib) in combination with Keytruda (pembrolizumab) for the treatment of patients with advanced endometrial carcinoma.¹

In early May 2021, AstraZeneca's Tagrisso (osimertinib), a post-surgery treatment for lung cancer, was the first drug to receive approval from the UK's Medicines and Healthcare products Regulatory Agency under Project Orbis.¹

Project Orbis is born out of a need to streamline drug review for potentially life-saving cancer treatments. Countries upholding similar review standards and criteria could bolster patients’ access globally. 

The three regulatory agencies collaboratively reviewed an application which allowed for simultaneous decisions in all three countries. The aim of this collaborative review was to identify any regulatory divergence across the review teams. Project Orbis is currently used only for supplemental oncology approvals, new indications for previously approved therapies. The FDA has discussed the possibility of extending the use of international collaboration to New Drug Applications or original Biologics License Applications review for oncology products.¹ 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. Delays in access to life-saving cancer treatment are partly due to different standards of care around the world which can slow the development of treatments. Collaboration among international regulators could allow patients with cancer to receive earlier access to products in other countries where there may be significant delays in regulatory submissions. Future drug development could benefit from greater uniformity of new global standards of treatment and lead to the optimal clinical trial design.

In 2010, for example, the average time for Health Canada to approve a prescription medication was 448 days; the European Medicines Agency took 319 days, and the American Food and Drug Administration took 299 days. For four years between 2007 and 2011, Health Canada took longer to approve new medicines than the FDA (Sunrise House Treatment Center, 2019).²

In future reviews, Project Orbis may expand and collaborate with other countries.¹

1. U.S. Food and Drug Administration. 2021. Project Orbis: Global Collaborative Oncology Review Program. [online] Available at: <https://www.fda.gov/science-research/fda-grand-rounds/project-orbis-global-collaborative-oncology-review-program-05132021-05132021> [Accessed 10 January 2021].

2. Sunrise House. 2019. Prescription Drugs: The United States vs. Canada | Sunrise House. [online] Available at: <https://sunrisehouse.com/prescription-drug-addiction-recovery/usa-canada/> [Accessed 10 January 2021].