Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Mini oral session - Policy and preventive strategies

1692MO - Is project Orbis successful? The Swiss perspective


23 Oct 2023


Mini oral session - Policy and preventive strategies


Targeted Therapy;  Immunotherapy;  Cancer Research

Tumour Site


Matea Pavic


Annals of Oncology (2023) 34 (suppl_2): S925-S953. 10.1016/S0923-7534(23)01945-2


M. Pavic1, Q. Li1, E. Atiek2, A. Wolfer1, U. Rohr1

Author affiliations

  • 1 Clinical Assessment, Swissmedic Swiss Agency for Therapeutic Products, 3012 - Bern/CH
  • 2 Regulatory Assessment, Swissmedic Swiss Agency for Therapeutic Products, 3012 - Bern/CH


This content is available to ESMO members and event participants.

Abstract 1692MO


An expedited market access for novel, effective & innovative drugs is warranted for patients. Swissmedic (SMC, Swiss Agency for Therapeutic Products) has participated since 2020 in Project Orbis, an US FDA launched collaborative parallel-review program where regulatory agencies remain decision-independent. We present the impact of the first 2 Project Orbis years from a SMC perspective.


We compared submission gaps (time between submission to FDA [1st] and SMC [2nd]), approval rates, consensus decision rates, and the approved indication labels between SMC and FDA for the 31 market authorization applications (MAA) in oncology submitted through Project Orbis (Orbis MAA) and the 41 oncology applications submitted in a conventional way to SMC (non-Orbis MAA) during 2020-2021. Assessment times at SMC were evaluated for Orbis and non-Orbis MAA with a decision until 6/2022.


The median gap between submission to the FDA and SMC was 33.0 days (range: 7, 337) for Orbis MAA versus 168.0 days (range: -359, 1593) for non-Orbis MAA. The median assessment time at SMC was 235.5 days (range: 52, 476) for Orbis MAA and 314.0 days (range: 115, 542) for non-Orbis MAA. Approval rate at SMC was consistent with 76.9% for Orbis and 75.6% for non-Orbis MAA compared to 96.2% and 100% at the FDA, respectively. Consensus decision between SMC and FDA was with 80.8% numerically higher for Orbis as compared to 75.6% for non-Orbis MAA. Divergent decisions in Orbis MAA were due to different interpretations on trial design (uncontrolled), lack of benefit in subgroups (histology, race), and lack of overall survival (OS) benefit or immature OS data. Less labels with differences in indication wording between SMC and FDA was observed in Orbis than in non-Orbis MAA (60% vs 67.7%). Similarly, stricter label indications at SMC were reduced with Project Orbis from 61.3% to 50% with non-Orbis.


Project Orbis is successful for SMC because (1) Submission gaps and review times for oncology applications submitted to SMC are significantly reduced by Project Orbis, fostering a faster patient access. (2) Consensus decision rates are increased and indication differences and strictness between SMC and FDA are reduced with Project Orbis, potentially due to joint discussion amongst agencies.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

The authors.


Has not received any funding.


All authors have declared no conflicts of interest.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings
  • Necessary cookies enable core functionality. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences.