Its tissue-agnostic approval was based on the phase I/II LIBRETTO-001 trial (NCT03157128), in which an initial cohort of 41 patients with locally advanced or metastatic RET fusion-positive solid tumors (excluding NSCLC and thyroid cancer) demonstrated an ORR of 43.9% (95% CI: 28.5–60.3) and a mDOR of 24.5 months (95% CI: 9.2–NE) [24]. This evidence concerns the gene RET and non-small cell lung carcinoma.