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Thursday, January 16, 2020 3:20:25 PM
FDA takes second action under international collaboration, approves new treatment option for patients with chronic lymphocytic leukemia
November 21, 2019
https://www.fda.gov/news-events/press-announcements/fda-takes-second-action-under-international-collaboration-approves-new-treatment-option-patients
Today, as part of Project Orbis, a collaboration with the Australian Therapeutic Goods Administration (TGA) and Health Canada, the U.S. Food and Drug Administration granted supplemental approval to Calquence (acalabrutinib) for the treatment of adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). This new approved indication for Calquence provides a new treatment option for patients with CLL or SLL as an initial or subsequent therapy.
“Today, as part of a U.S., Australian and Canadian collaboration known as Project Orbis, the U.S. approved a new treatment option for those living with chronic lymphocytic leukemia or small lymphocytic lymphoma. The FDA’s Project Orbis provides a framework for concurrent submission and review of oncology drug applications among the FDA’s international partners,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research. “We are pleased to continue working alongside our Australian and Canadian colleagues to facilitate new treatment options for patients and the FDA looks forward to working with other countries in future application reviews.” . . .
In addition to the international collaboration with Australia and Canada, this review used the Real-Time Oncology Review (RTOR) pilot program, which can streamline the submission of data prior to the completion and submission of the entire clinical application. RTOR, and its accompanying Assessment Aid, facilitated discussions among the regulatory agencies. These applications were approved four months prior to the FDA goal date. The FDA granted this application Priority Review and Breakthrough Therapy designation. The FDA granted approval of Calquence to AstraZeneca.
Project Orbis
https://www.fda.gov/about-fda/oncology-center-excellence/project-orbis
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.
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