Project Orbis: quicker access to promising cancer treatments

Scientific analysis confirms successful Swissmedic participation in international initiative to expedite access to innovative cancer drugs


Swissmedic, the Swiss Agency for Therapeutic Products has participated in Project Orbis since 2020. The initiative started by the US Federal Drugs Administration’s Oncology Center of Excellence enables parallel assessment of marketing authorisation applications for oncology products by international partner authorities. The FDA is responsible for overall coordination. However, each participating country remains completely independent as regards the final authorisation decision.

Swissmedic experts scientifically evaluated the impact of the programme on the submission and review processes for medicinal product authorisations in Switzerland. Their aim was to assess its effects from Swissmedic’s point of view.

Simultaneous assessment has made it possible to significantly reduce the submission gap (i.e. the difference between the submission dates to different authorities) and the duration of assessment for innovative cancer medicines. As a result, patients have rapid access to promising new cancer therapies. This successful international collaboration is set to continue.

Swissmedic has participated in the FDA’s Project Orbis since 2020. Within Project Orbis, marketing authorisation applications for new cancer medicines and new indications can be submitted in a coordinated manner to different therapeutic products authorities and be reviewed by them in parallel. The aim of Orbis is to provide patients in a range of countries with rapid access to innovative cancer therapies, by reducing the submission gap1 and enabling faster, yet independent, authorisation decisions.

Experts at Swissmedic and the Geneva University Hospital (HUG) oncology department reviewed the impacts of Project Orbis during its first two years. The analysis published in the scientific journal The Lancet Oncology compares submission data, the rate of positive or negative authorisation decisions and the approved indications for applications submitted to Swissmedic and the FDA, both within and outside Project Orbis.

Thirty-one marketing authorisation applications for new active substances and indication extensions for oncology products that were submitted within Project Orbis (Orbis MAAs2) between 1 January 2020 and 31 December 2021 were compared with 41 marketing authorisation applications processed outside Project Orbis (non-Orbis MAAs).

For the analysis of throughput times, authorisation decisions up to 30 June 2022 were evaluated, while the comparison of approvals or rejections took into account the oncology marketing authorisation applications submitted and evaluated outside Project Orbis between January 2009 and December 2018.

The submission gap3 between the date of submission to the reference authority (the FDA) and submission to Swissmedic was 33 days for Orbis MAAs versus 168 days for non-Orbis MAAs. Review time3 at Swissmedic was 235.5 days for Orbis MAAs versus 314 days for non-Orbis MAAs.

As regards new applications for new active substances (NA NAS), Swissmedic and FDA decisions were identical in 88% of Orbis MAAs and in 82% of non-Orbis MAAs. The NA NAS approval rate in Switzerland – even taking into consideration the ten-year comparison before Orbis – is therefore constant at between 82% and 88%. Swissmedic approval rates (NA NAS and indication extensions) were very similar for the applications submitted within and outside Project Orbis (77% for Orbis MAAs and 76% for non-Orbis MAAs). The authorities thus tended to diverge in their decisions as regards indication extensions more than as regards NA NAS applications.

Interpretation of the results shows that participation in Project Orbis significantly reduces submission and review times for marketing authorisation applications in the oncology area at Swissmedic and has increased the consistency of approval decisions between the two authorities. The initiative contributes to making innovative cancer medicines available to patients in Switzerland sooner and more quickly.

That being so, optimised authorisation processes for innovative medicinal products have not previously been, nor are they now, at the expense of patient safety; rather they are always based on the necessary evidence in the risk-benefit assessment. This is one of the reasons why in a few applications the two authorities may reach different decisions.

The positive experiences with parallel inspection approaches by different authorities may help reduce a submission gap and accelerate medicinal product authorisations for innovative medicines in therapeutic areas beyond oncology.

[1] The submission gap is defined as the time between the date of submission to the reference authority and the date of submission to Swissmedic.

[2] Marketing authorisation applications

[3] Median values