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


Advanced or metastatic disease

Pralsetinib monotherapy

Regimen

Study Years of enrollment Evidence
Subbiah et al. 2021 (ARROWRET) 2017-2020 Phase 1/2 (RT)

Note: this trial is denoted as ARROWRET to distinguish from other trials of the same name. This is the phase 2 dosing.

Biomarker eligibility criteria

  • RET fusion positive

Targeted therapy

Continued indefinitely

References

  1. ARROWRET: 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 PubMed NCT03037385

Selpercatinib monotherapy

Regimen

FDA-recommended dose
Study Years of enrollment Evidence
Wirth et al. 2020 (LIBRETTO-001) 2017-2019 Phase 1/2 (RT)

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

  1. LIBRETTO-001: 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 PubMed NCT03157128