Project Orbis: findings after the first year

Analysis report on regulatory measures to promote innovative cancer drugs


On 17 September 2019, the FDA launched a project named Orbis to accelerate the authorisation processes for new cancer drugs and new indications worldwide. Swissmedic is also involved in this initiative, which is funded by the FDA’s Oncology Center of Excellence (OCE). An analysis at the end of the first year shows that the global collaboration is working and is providing patients with faster access to new cancer treatments.

Swissmedic has been participating in Project Orbis since the beginning of 2020. On 26 May 2020, Swissmedic was able to approve a new active substance (tucatinib) for the treatment of breast cancer as part of Orbis for the first time. In addition to Swissmedic, the regulatory authorities of Australia (TGA), Canada (Health Canada), the United Kingdom (MHRA), Japan (PMDA), Singapore (HSA) and Brazil (ANVISA) are also involved in the project.

Thanks to concurrent submission and parallel review by the participating therapeutic products regulatory authorities, medicinal products for the treatment of cancer are available to patients earlier. This means that differing submission (the “submission gap”) and approval periods can be significantly reduced.

The global collaboration between the drug regulatory authorities is also highly relevant to health policy for other urgent health issues such as the COVID-19 pandemic.

An analysis of Project ORBIS investigated whether the overarching aims have been achieved after the first year of the project. The article describes the specific implementation, challenges and future direction of Project Orbis and provides an insight into the initial findings between June 2019 and June 2020.

The evaluations show that in this period 60 applications (new authorisations and new indications) were received by the participating regulatory authorities as part of Project Orbis, of which 38 have already been approved.

Further links