Project Orbis: Global Collaborative Review Program.

Area of Science:

• Oncology
• Regulatory Science
• Global Health

Background:

• The U.S. Food and Drug Administration (FDA) Oncology Center of Excellence launched Project Orbis in 2019.
• This global collaborative review program aims to expedite patient access to innovative cancer treatments.
• It involves concurrent submission, review, and regulatory action for significant oncology marketing applications.

Purpose of the Study:

• To evaluate the initial impact and operational efficiency of Project Orbis in its first year.
• To assess the timeframes for submission and approval of oncology marketing applications within the program.
• To gauge the commitment of participating regulatory health authorities (RHAs) for future program expansion.

Main Methods:

• Project Orbis involves regulatory health authorities from Australia, Brazil, Canada, Singapore, and Switzerland.
• Applications are submitted concurrently for review.
• The FDA coordinates application selection and review, while each country retains independent decision-making authority.

Main Results:

• In its first year (June 2019-June 2020), Project Orbis received 60 oncology marketing applications (16 unique projects).
• 38 applications were approved, with new molecular entities accounting for 28% of submissions.
• Median time-to-approval was comparable between the FDA (4.2 months) and Project Orbis Partners (4.4 months).

Conclusions:

• Project Orbis successfully facilitated timely access to innovative cancer therapies across multiple countries.
• The program demonstrated efficiency with comparable approval timelines to the FDA.
• Participating countries expressed strong commitment to the program's continuation and expansion.