Presentation (CTI)

OBJECTIVES: Project Orbis, launched by the FDA in 2019, enables parallel regulatory reviews across multiple countries to reduce international approval delays for oncology drugs. However, reimbursement remains delayed, limiting patient access. Ontario’s new Funding Accelerated for Specific Treatments (FAST) program, starting in 2026, aims to fast-track public funding for high-priority cancer drugs. This study evaluates the impact of Project Orbis on regulatory timelines and explores how FAST may synergize to accelerate patient access.
METHODS: We reviewed published literature and regulatory reports describing Project Orbis’ framework and impact on submission gaps and review timelines across participating countries. Data from Switzerland and Canada was analyzed to illustrate changes in regulatory processes and approval speed. We then examined the design of Ontario’s new FAST program to identify opportunities with Project Orbis that could result in reducing time from regulatory approval to public funding.
RESULTS: Project Orbis significantly reduced the median delay between FDA and Health Canada approvals by 175.0 days. Submission gaps in Switzerland also decreased by 135.0 days (p<0.01) and review times were shortened by 78.5 days (p<0.01). Despite these improvements, regulatory acceleration did not translate into faster real world patient access as health economic reviews and provincial funding timelines offset the regulatory gains. The new Ontario FAST program prioritizes drugs with meaningful therapeutic benefit and positive HTA recommendations to create a dual acceleration model which targets the bottlenecks that limit the impact of Project Orbis.
CONCLUSIONS: Regulatory acceleration alone does not guarantee timely patient access. By combining Project Orbis with funding initiatives like FAST, “approval-to-access” gaps could close and foster integrated global oncology pathways. Future policy should focus on integrating regulatory, HTA and reimbursement timelines to achieve the full potential of Project Orbis to maximize patient access to life-saving treatments.