Conditional approval of oncology medicines in Europe (2017-2022): evidence maturity, regulatory outcomes, clinical benefit and downstream access

Background

Conditional marketing authorisation (CMA) is a European regulatory pathway that enables earlier access to medicines for serious conditions while allowing additional evidence generation after approval. Important questions remain regarding the maturity of supporting evidence, subsequent regulatory outcomes, clinical benefit, and patient access. We characterised the evidentiary basis, regulatory outcomes, clinical benefit, clinical practice guideline incorporation, and downstream access of oncology medicines granted CMA between 2017 and 2022.