What does the FDA’s traditional approval of selpercatinib for RET fusion-positive solid tumors mean?

In July 2026, the FDA granted traditional approval to selpercatinib (Retevmo) for adults and children with RET fusion-positive solid tumors that progressed after prior therapy or lacked alternatives. This upgrade from accelerated to full approval was based on LIBRETTO trial data showing durable responses across multiple cancer types, reinforcing Retevmo’s role as a tissue‑agnostic therapy.