Effect of Project Orbis participation by the Swiss regulator on submission gaps, review times, and drug approval decisions between 2020 and 2022: a comparative analysis

• Published in: The lancet oncology 2024-06, Vol.25 (6), p.770-778
• Main Authors: Zosso-Pavic, Matea, Li, Qiyu, Atiek, Eiman, Wolfer, Anita, Rohr, Ulrich-Peter
• Format: Article
• Language: English
• Subjects: Antineoplastic Agents - therapeutic use; Collaboration; Comparative analysis; Corporate sponsorship; Decision making; Drug Approval - legislation & jurisprudence; Drugs; FDA approval; Hematology; Humans; Marketing; Neoplasms - drug therapy; Oncology; Patients; Regulatory agencies; Statistical analysis; Switzerland; Time Factors; United States; United States Food and Drug Administration
• ISSN: 1470-2045; 1474-5488; 1474-5488
• DOI: 10.1016/S1470-2045(24)00158-X

Expedited market access for novel and efficacious drugs is warranted for patients. Since 2020, Swissmedic (The Swiss Agency for Therapeutic Products) has been participating in Project Orbis, a collaborative parallel-review programme launched by the US Food and Drug Administration (FDA) in 2019 to expedite patient access to cancer drugs. This programme allows regulatory agencies to remain independent in their decisions. We aimed to evaluate the effect of the first 2 years of Project Orbis from the Swissmedic perspective. In this comparative analysis, we compared submission gap (time between submission at the FDA and Swissmedic), review time, approval and consensus decision rate, and the approved indications between Swissmedic and the FDA for marketing authorisation applications (MAAs) in oncology submitted to Swissmedic through Project Orbis (Orbis MAAs) or outside of Project Orbis (non-Orbis MAAs) from Jan 1, 2020, to Dec 31, 2021. Swissmedic review time was evaluated with a decision until June 30, 2022. For the decision comparison analysis, non-Orbis oncology MAAs submitted and evaluated from Jan 1, 2009, to Dec 31, 2018 (referred to as the pre-Orbis era) were also considered. Inferential statistics were done using Wilcoxon rank-sum test and the 95% CI for the median was based on binomial distribution. For each hypothesis testing, the significance level was set to 5%. No correction for multiple testing was performed. We analysed the submission gap, review time, and regulatory decision for 31 Orbis MAAs and 41 non-Orbis MAAs during the Orbis era. The median submission gap was 33·0 days (95% CI 19·0–57·0) for Orbis MAAs versus 168·0 days (56·0–351·0) for non-Orbis MAAs (p