The U.S. Food and Drug Administration (FDA) Oncology Center of Excellence recently published an overview of Project Orbis and the regulatory actions within the first year of its implementation (June 2019 to June 2020).
Project Orbis is a global collaborative review program intended to facilitate faster patient access to high-impact cancer therapies and standardize pivotal oncology clinical trials. We previously reported the first simultaneous approvals of LENVIMA (lenvatinib) and KEYTRUDA (pembrolizumab) combination therapy by Health Canada, the FDA, and the Australian Therapeutic Goods Administration under Project Orbis in September 2019. Since then, four more countries (Singapore, Switzerland, Brazil and the United Kingdom) have joined Project Orbis. While each Project Orbis partner remains fully independent with respect to regulatory decision-making, increased efficiency is achieved by direct collaboration with the application review, alignment of the review processes and the use of a core review document.
Under this collaborative framework, selection of marketing applications is coordinated by the FDA. For an application to be considered as a Project Orbis application, participation of at least one other Project Orbis partner is required. The sponsors have the discretion to select the number of partners.
According to a recent publication by the Project Orbis partnership, the program received 60 oncology marketing applications in the first year, resulting in 38 approvals internationally (including eight approvals by Health Canada). All of the applications met the FDA criteria for priority review, i.e. the drug is intended to treat a serious condition and if approved, would provide a significant improvement in safety or effectiveness of the treatment, prevention, or diagnosis of the serious condition. Based on the data analyzed, the median time-to-approval was similar between the FDA and other Project Orbis partners, and the gap between submission to the FDA and other partners was only 0.6 months.
Should you have any questions, please do not hesitate to contact a member of the Life Sciences Regulatory & Compliance Group.
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