1692MO - Is project Orbis successful? The Swiss perspective

Background

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.

Methods

We compared submission gaps (time between submission to FDA [1^st] and SMC [2^nd]), 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.

Results

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.

Conclusions

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.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.