Eli Lilly announced Phase 3 LIBRETTO-432 results on June 1, 2026. The trial evaluated selpercatinib as adjuvant therapy in patients with early-stage RET fusion-positive non-small cell lung cancer following curative-intent surgery. Retevmo demonstrated an 83% reduction in the risk of disease recurrence or death compared to placebo. The primary endpoint of disease-free survival was met with high statistical significance. RET fusions occur in approximately 1–2% of NSCLC cases.
Retevmo holds accelerated FDA approval since May 2020 for metastatic RET fusion-positive NSCLC and thyroid cancers. The adjuvant indication requires a supplemental New Drug Application under 21 CFR 314.71. EMA approved selpercatinib as Retsevmo in 2021 for advanced RET-altered tumors. BrunoSan DB confirms pending EMA type II variation for label expansion. FDA Oncologic Drug Advisory Committee review is likely given the magnitude of effect. A decision follows the six-month Class I review cycle.
Gavreto (pralsetinib), the only direct RET competitor, was withdrawn from the US market in 2024. Lilly's monotherapy positioning in early-stage disease creates a potential first-mover advantage. Chemotherapy remains the current standard adjuvant for resected NSCLC but lacks biomarker selection. Roche's Alecensa leads the ALK-positive adjuvant segment by parallel mechanism. Investors monitor the sNDA acceptance announcement expected before Q4 2026 earnings.