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Investigation reveals variability in regulatory approval types for biomarker-defined NSCLC therapies, suggesting a clearer pathway for future treatments.
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.
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Mejia et al. (2026) studied this question.
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