Posted by Michael Wonder on 19 Jul 2026
FDA grants traditional approval to selpercatinib for locally advanced or metastatic RET fusion-positive solid tumors
14 July 2026 - Today, the FDA granted traditional approval to selpercatinib (Retevmo, Eli Lilly) for adult and pediatric patients two years of age and older with locally advanced or metastatic solid tumors with a RET gene fusion, as detected by an FDA approved test, that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options.
Selpercatinib received accelerated approval for this indication for adult patients in 2022 and for pediatric patients two years of age and older in 2024.
