The Future of all‐Comers Trials in the Era of Precision Oncology

Approvals of new therapeutics are increasingly restricted to specified biomarker subgroups, even where pivotal clinical studies meet primary endpoints in broader "all-comers" populations. In this article, we discuss the potential factors that increase the likelihood of approvals in biomarker subpopulations rather than all-comers. We outline mitigation strategies drug developers can pursue to plan for potential label restrictions and achieve companion diagnostic readiness, ensuring patients receive timely access to innovative medicines.