Thyroid cancer, RET-positive

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Note: these are regimens tested in biomarker-specific populations, please see the main thyroid cancer page for other regimens.
Last updated on 2024-07-23:2 regimens on this page
2 variants on this page
=Guidelines=
Given the rapid change in evidence in many areas of hematology/oncology, readers are encouraged to consider any guideline published 5+ years ago to be for historical purposes, only.
==NCCN==
*NCCN does not currently have guidelines at this granular level; please see NCCN Guidelines - Thyroid Carcinoma.
=Advanced or metastatic disease=
==Pralsetinib monotherapy==
===Regimen===
Study 	Dates of enrollment	Evidence
Subbiah et al. 2021 (ARROWRET-thyroid)	2017-2020 	Phase 1/2 (RT)
Note: this trial is denoted as ARROWRET-thyroid to distinguish from other arms of this basket trial. This was the recommended phase 2 dosing.
====Biomarker eligibility criteria====
*RET fusion positive
====Targeted therapy====
*Pralsetinib (Gavreto) 400 mg PO once per day
Continued indefinitely
===References===
#ARROWRET-thyroid: Subbiah V, Hu MI, Wirth LJ, Schuler M, Mansfield AS, Curigliano G, Brose MS, Zhu VW, Leboulleux S, Bowles DW, Baik CS, Adkins D, Keam B, Matos I, Garralda E, Gainor JF, Lopes G, Lin CC, Godbert Y, Sarker D, Miller SG, Clifford C, Zhang H, Turner CD, Taylor MH. Pralsetinib for patients with advanced or metastatic RET-altered thyroid cancer (ARROW): a multi-cohort, open-label, registrational, phase 1/2 study. Lancet Diabetes Endocrinol. 2021 Aug;9(8):491-501. Epub 2021 Jun 9. Erratum in: Lancet Diabetes Endocrinol. 2021 Oct;9(10):e4. link to original article dosing details in manuscript have been reviewed by our editors EuroPMC NCT03037385
==Selpercatinib monotherapy==
===Regimen===
FDA-recommended dose
Study 	Dates of enrollment	Evidence
Wirth et al. 2020 (LIBRETTO-001thyroid)	2017-2019 	Phase 1/2 (RT)
Note: Wirth et al. 2020 only mentioned the 160 mg dosing; the FDA label includes weight-based recommendations.
====Biomarker eligibility criteria====
*RET fusion-positive thyroid cancer
*RET-mutant medullary thyroid cancer 
====Targeted therapy====
*Selpercatinib (Retevmo) by the following weight-based criteria:
**Less than 50 kg: 120 mg PO twice per day
**50 kg or more: 160 mg PO twice per day
Continued indefinitely
===References===
# LIBRETTO-001thyroid: Wirth LJ, Sherman E, Robinson B, Solomon B, Kang H, Lorch J, Worden F, Brose M, Patel J, Leboulleux S, Godbert Y, Barlesi F, Morris JC, Owonikoko TK, Tan DSW, Gautschi O, Weiss J, de la Fouchardière C, Burkard ME, Laskin J, Taylor MH, Kroiss M, Medioni J, Goldman JW, Bauer TM, Levy B, Zhu VW, Lakhani N, Moreno V, Ebata K, Nguyen M, Heirich D, Zhu EY, Huang X, Yang L, Kherani J, Rothenberg SM, Drilon A, Subbiah V, Shah MH, Cabanillas ME. Efficacy of Selpercatinib in RET-Altered Thyroid Cancers. N Engl J Med. 2020 Aug 27;383(9):825-835. link to original article dosing details in manuscript have been reviewed by our editors link to PMC article EuroPMC NCT03157128
##Update: Wirth LJ, Brose MS, Subbiah V, Worden F, Solomon B, Robinson B, Hadoux J, Tomasini P, Weiler D, Deschler-Baier B, Tan DSW, Maeda P, Lin Y, Singh R, Bayt T, Drilon A, Cassier PA. Durability of Response With Selpercatinib in Patients With RET-Activated Thyroid Cancer: Long-Term Safety and Efficacy From LIBRETTO-001. J Clin Oncol. 2024 Sep 20;42(27):3187-3195. Epub 2024 Aug 2. link to original article link to PMC article EuroPMC
Category:Thyroid cancer regimens
Category:Biomarker-specific pages
Category:Endocrine cancers
Category:Head and neck cancers