Eli Lilly Retevmo Achieves 83% Risk Reduction in Lung Cancer Eli Lilly's Retevmo met its primary endpoint. Phase 3 LIBRETTO-432 study succeeded. Adjuvant therapy reduced recurrence risk. 83% reduction in disease recurrence or death. Eli Lilly announced positive Phase 3 results for Retevmo (selpercatinib) in early-stage RET fusion-positive non-small cell lung cancer (NSCLC). The LIBRETTO-432 study, evaluating Retevmo as an adjuvant therapy, demonstrated an 83% reduction in the risk of disease recurrence or death. This significant outcome establishes RET fusions as a critical biomarker, potentially redefining the standard of care for this patient population. This strong efficacy data will support new regulatory submissions. Eli Lilly plans to discuss these results with global authorities, including the FDA and EMA. The FDA's accelerated approval pathway (21 CFR Part 314, Subpart H) could be relevant for a rapid review. EMA has previously granted conditional marketing authorization for Retevmo in advanced RET fusion-positive NSCLC, indicating a favorable regulatory history. This breakthrough positions Retevmo ahead of competitors like Roche's Gavreto (pralsetinib). The adjuvant setting represents a significant market expansion opportunity. This data could shift treatment paradigms, making RET fusion testing standard for early-stage NSCLC. Eli Lilly anticipates submitting these data to regulatory bodies by Q4 2026.