In the LIBRETTO-121 trial's primary efficacy population of 25 pediatric and young adult patients with RET-altered solid tumors (including RET-altered thyroid cancer) that had not responded to available therapies, selpercatinib…
In the LIBRETTO-121 trial's primary efficacy population of 25 pediatric and young adult patients with RET-altered solid tumors (including RET-altered thyroid cancer) that had not responded to available therapies, selpercatinib…
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FDA Approvals
Regulatory approval is separate from evidence certainty and from guideline position. Approval applies only to the exact indication stated in each jurisdiction record.
Patients aged 2 to 20 with locally advanced or metastatic RET-altered solid tumors (including RET-altered thyroid cancer) that had not responded to available therapies, enrolled in the primary efficacy population of the international, single-arm, multicohort, phase 1/2 LIBRETTO-121 trial.
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Last reviewed
2026-08-13
Regulatory status by jurisdiction
United States (FDA)
Status
FDA-approved for the exact stated cancer/use
Indication
Pediatric patients aged 2 and older with RET-altered metastatic thyroid cancer, or other RET-altered solid tumors that are advanced or metastatic and require systemic therapy, that have progressed on or are intolerant to prior therapy, or for whom there is no satisfactory alternative treatment.
Safety and efficacy of selpercatinib in pediatric patients with RET-altered solid tumors: updated results from LIBRETTO-121 (Journal of Clinical Oncology, ASCO Annual Meeting). DOI 10.1200/JCO.2024.42.16_suppl.10022.
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