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# Full Approval Given to Lilly's Retevmo
- URL: https://www.fdaweb.com/full-approval-given-to-lillys-retevmo/
- Published: 2026-07-14T12:00:00.000Z
- Updated: 2026-09-14T13:42:51.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161456

FDA has converted the accelerated approval of Eli Lilly's Retevmo (selpercatinib) into a traditional approval for treating adult and pediatric patients with locally advanced or metastatic RET fusion-positive solid tumors.

The agency announced Tuesday that selpercatinib is now fully approved for adults and children ages two years and older whose RET fusion-positive solid tumors have progressed following prior systemic therapy or for whom no satisfactory alternative treatment options exist. Patients must have tumors identified using an FDA-approved diagnostic test.

Selpercatinib initially received accelerated approval for adult patients with RET fusion-positive solid tumors in 2022, with the indication expanded to pediatric patients in 2024.

The traditional approval was supported by results from the ongoing Phase 1-2 LIBRETTO-001 basket trial, which enrolled patients with RET fusion-positive cancers other than non-small cell lung cancer and thyroid cancer. Among 75 evaluable patients whose disease had progressed after prior treatment or who lacked satisfactory treatment alternatives, the drug achieved an overall response rate of 47%, with a median duration of response of 24.5 months.

FDA also reviewed data from the LIBRETTO-121 trial evaluating pediatric and young adult patients with advanced RET fusion-positive solid tumors. Clinical responses were observed in patients with congenital infantile fibrosarcoma, spindle cell sarcoma and RET fusion-positive thyroid cancer, supporting the expanded pediatric indication.

Selpercatinib is a selective RET kinase inhibitor designed to target tumors driven by RET gene fusions, which occur across multiple rare and common cancer types.