DIA EUROPE 2019

Biological drivers that define cancer course across anatomical sites and histologies offer an opportunity to select populations sensitive to specific drugs based on those drivers, independently of the specific site or histology. The FDA regulatory approvals of the first medicines in 2017 marked an important milestone that a cancer treatment may be approved based on a common biomarker rather than the anatomic location in the body where the tumor originated, and therefore established a precedent for histology-independent labels. With increasing accessibility to genetic analysis tools such as next-generation sequencing, this type of personalized therapy has become a reality, both during clinical development and in clinical practice. This session aims to provide an exchange of views from different stakeholders about situations where a site and histology-independent clinical development might be a viable option and the associated challenges in terms of drug development, benefit-risk evaluation and health-technology assessment. A second part of the discussion mainly focusing on challenges for the value assessment of these drugs will be held in session 0606.