Health Canada collaborates with U.S. and Australian regulators through Project Orbis: A framework for concurrent review of oncology products

Author:  Preetha Prabhu

On Dec. 6, 2019, Health Canada issued a News Release titled “International collaboration among Canadian, U.S. and Australian regulators leads to new options for the treatment of cancer”. The News Release provides highlights on Health Canada’s collaborative efforts with the U.S. Food and Drug Administration (FDA) and Therapeutic Goods Administration (TGA) which allows simultaneous regulatory review and thus ensuring Canadians an earlier access to the latest treatments especially for cancers, rare diseases and conditions with limited treatment options. The collaborative review is conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence.

As per FDA, Project Orbis provides a framework for concurrent submission and review of oncology products among international partners. Collaboration among international regulators may allow patients with cancer to receive earlier access to products in those countries where there may be significant delays in regulatory submissions, regardless of whether the product has received FDA approval.

On Sep. 20, 2019, Health Canada authorized a new treatment for women who have advanced endometrial cancer through the combined use of Lenvima (lenvatinib) and Keytruda (pembrolizumab). This was the first review conducted under Project Orbis. The three regulatory agencies collaboratively reviewed this application, allowing for simultaneous decisions in all three countries. The aim of this collaborative review was to identify any regulatory divergence across the review teams. In addition, the regulators also exchanged drug labels to learn about any potential differences.

On Nov. 21, 2019, after the second review conducted under Project Orbis, Health Canada authorized Calquence (acalabrutinib) for adults with chronic lymphocytic leukemia (CLL). This represents another treatment option for these patients.

Building on this foundation of cooperation, Health Canada will continue to seek opportunities to work with its international partners to bring needed treatments to Canadians sooner.

References:

·       Health Canada News Release dated Dec. 6, 2019:  https://www.canada.ca/en/health-canada/news/2019/12/international-collaboration-among-canadian-us-and-australian-regulators-leads-to-new-options-for-the-treatment-of-cancer.html

·       Project Orbis (US FDA): https://www.fda.gov/about-fda/oncology-center-excellence/project-orbis