OBJECTIVES: Project Orbis is an FDA initiative which provides framework for concurrent submission and review of oncology products among international partners. Following the separation of the UK from the EU, the MHRA joined Project Orbis in January 2021. A key benefit of the MHRA joining was seen as faster access to promising cancer drugs. This research assessed whether marketing authorization has accelerated in Great Britain (England, Scotland, and Wales) compared to the EU for products assessed by Project Orbis.

METHODS: Project Orbis approvals from 1^st January 2021 to 30^th Jun 2022 for all Project Orbis Partners (POPs) were extracted from Prismaccess, the FDA, and the MHRA websites with corresponding approvals at the EMA.

RESULTS: Since January 2021, the most common therapeutic areas for therapies approved in any market via Project Orbis were NSCLC (27%), Gastric/Esophageal cancer (17%), and Breast cancer (13%). In this period, only 37% of FDA approvals via Project Orbis have been approved by the MHRA (11 vs 30). For all products approved by the MHRA via Project Orbis, the average delay in marketing authorisation between the FDA to MHRA (5.7 months) was shorter than from the FDA to EMA (7.8 months). For these products only one product, tebentafusp, was approved at the EMA before the MHRA.

CONCLUSIONS: MHRA participation in Project Orbis has resulted in faster average approvals compared to what would have been attained if Great Britain remained under the remit of the EMA centralized procedure. However, there have only been 11 MHRA approvals via Project Orbis so far and this data focusses on therapies the MHRA has chosen to assess. While this can be seen as an improvement in Great Britain, there is still scope for approvals to be expedited further though Project Orbis.