Project Orbis, an initiative of the FDA Oncology Center of Excellence (OCE), 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 other countries where there may be significant delays in regulatory submissions, regardless of whether the product has received FDA approval. 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. In 2004, FDA?s Office of Hematology and Oncology Products (OHOP) began holding regular teleconferences under a confidentiality agreement with other regulatory agencies to allow for exchange of information and collaboration on specific topics related to applications under review. Currently, OHOP holds a monthly teleconference with Australia?s Therapeutic Goods Administration, Health Canada, the European Medicines Agency, Japan?s Pharmaceuticals and Medical Devices Agency, and Switzerland?s Swissmedic. In addition, FDA and China?s National Medical Products Administration have initiated a quarterly meeting to discuss non-product specific regulatory issues facing worldwide drug development. The?first Project Orbis action?took place on September 17, 2019, in conjunction with the Australian Therapeutic Goods Administration and Health Canada.

Project Orbis FAQs

Q: Which countries were involved in the first Project Orbis collaborative review?? A: The U.S. Food and Drug Administration (FDA), the Australian Therapeutic Goods Administration (TGA) and Health Canada (HC) took part in this application review. Q: Will other countries be involved in future Project Orbis reviews? A: Other countries may be involved in future application reviews. Q: For the first Project Orbis review, what was the role of each country in the review process? A: 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. Q: Did the three countries issue the same drug labels for the two products involved? A: No. Each country has its own format for the drug label. The regulators exchanged drug labels to learn about any potential differences. Only minor differences were noted. In Canada, the approved indication was slightly different than the approved indication in the United States and Australia. Q: This was an FDA?accelerated approval. Do Canada and Australia use similar expedited approval programs? A: Health Canada used its conditional approval with conditions. TGA used its provisional approval with conditions of registration. Q: Will Project Orbis be used only for supplemental oncology approvals (new indications for previously approved therapies) or will it be extended to New Drug Applications or original Biologics License Applications? A: FDA and the other agencies will discuss the possibility of collaborating on NDA or BLA reviews for oncology products, but the process may be more complex due to proprietary information involved. Q: Does Project Orbis have anything to do with drug pricing or drug importation? A: No.

Additional Information

• FDA News Release:?FDA takes first action under new international collaboration with Australia and Canada designed to provide a framework for concurrent review of cancer therapies, approving treatment for patients with endometrial carcinoma(September 17, 2019)
• FDA Oncology Center of Excellence
• OCE?s?Real-Time Oncology Review?and?Assessment Aid
• FDA: Fast Track, Breakthrough Therapy, Accelerated Approval, and Priority Review