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.
2 regimens on this page
2 variants on this page
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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
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 contains dosing details in abstract PubMed 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 contains dosing details in manuscript PubMed NCT03157128