9/4/2023 0 Comments Orbis clinical drug safetyWhile it is important for CBER to learn what it can from Project Orbis, Marks said he wants to take that effort one step further for rare diseases, creating something akin to the World Health Organization’s prequalification process for vaccines. Most of these products also either have been approved by the partner countries, or application reviews are ongoing. The FDA’s website lists 68 product approvals in the US under Orbis. The initiative has since gained additional partners, including regulatory authorities in Brazil, Israel, Singapore, Switzerland and the UK. (Also see “ US FDA’s Project Orbis Could Streamline Global Clinical Trials In Cancer” – Pink Sheet, 17 Sep, 2019.) In September 2019, the FDA, Australian Therapeutic Goods Administration and Health Canada partnered on the first approval under Orbis, for Eisai Co., Ltd.’s kinase inhibitor Lenvima (lenvatinib) in combination with Merck & Co., Inc.’s PD-1 inhibitor Keytruda (pembrolizumab) for the treatment of certain patients with advanced endometrial carcinoma. Project Orbis provides a framework for concurrent submission and review of oncology products among international partners. “The US might have 20 patients, but that means EU probably has 30 or 40 patients, Japan might have another 10 patients, and some other high-income countries, put them together and you get to this magic 100 to 200 patients a year, which is where commercial viability starts to become real.” 68 Orbis Approvals “Especially when you think about some of the rarer diseases,” Marks continued. “A lot of these gene therapies have such small populations that are applicable to them in the United States that if we could expand those markets into other high-income countries, it would attract more developers, which would allow more diseases to be covered.” “This concept that FDA can serve as almost a reference regulatory authority for other countries that might approve things at the same time or near same time, I think is really important,” Marks said. The US Food and Drug Administration is eyeing potential adoption of a Project Orbis-type approach for cell and gene therapies to treat rare diseases.Ī process where the FDA can coordinate reviews with other regulators would allow for better leveraging of global patient populations with ultra-rare diseases and attract more commercial interest in development for a particular disease area, Center for Biologics Evaluation and Research Director Peter Marks said at the Prevision Policy/Friends of Cancer Research Biopharma Congress meeting on 13 February.
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