133P Regulatory divergence in EMA approvals for targeted therapies in oncogene addicted NSCLC

CHMP decisions for biomarker-defined NSCLC therapies have shown some variability in approval type (conditional vs. full), the scope of the indication (line-agnostic vs. setting-specific) and in the evidence required for regulatory decision-making. Investigation of the factors behind divergent regulatory outcomes could help clarify the regulatory pathway for future drugs targeting molecularly-defined subsets of NSCLC.