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갑상선암: 국가별 치료 선택지

이 페이지는 한국어 임상 치료 설명을 새로 쓰지 않습니다. 권위 출처, 진료 전 정리 질문, 임상시험 검색어, 구축 상태를 보여주는 안전한 시작점입니다.

선택지 정리됨고형암최종 확인 2026.06

국가별 선택지

국가별 치료 선택지

공식 규제·평가 기관 출처를 바탕으로 한 국가별 승인·접근 상태입니다. 무엇이 어디에 존재하는지를 보여줄 뿐, 추천이 아닙니다.

United States

  • dabrafenib (Tafinlar) + trametinib (Mekinist)[1]FDA-approvedBRAF V600E mutation detected by an FDA-approved test; locally advanced or metastatic BRAF V600E-positive ATC when satisfactory locoregional treatment options are lacking. · This verifies current U.S. label status only. It does not establish insurer coverage, sequencing versus surgery-radiation, or suitability when a satisfactory locoregional option still exists. Confidence/conflicts: High for current U.S. labelled indication scope because both current DailyMed labels align on disease, biomarker, and no-satisfactory-locoregional-treatment gating. No conflicting primary U.S. source was reviewed in this cycle.
  • dabrafenib (Tafinlar) plus trametinib (Mekinist)[2]FDA-approvedBRAF V600E mutation; locally advanced or metastatic anaplastic thyroid cancer with BRAF V600E mutation and no satisfactory locoregional treatment options. · FDA orphan listing confirms approved labeled indication but not full current prescribing information. BRAF V600E testing and current labels should be checked. Confidence/conflicts: high for FDA approval-list wording; current label refresh remains a gap. No conflict identified.
  • entrectinib (Rozlytrek)[3]FDA-approvedNTRK gene fusion; NTRK fusion-positive thyroid cancer in metastatic disease or in unresectable or surgery-morbid disease after standard-treatment failure or when no satisfactory alternative exists. · This is an NCI summary of a tissue-agnostic FDA approval rather than a thyroid-specific label. It should not be generalized to all thyroid cancers or to patients without a confirmed NTRK fusion. Confidence/conflicts: High for the NCI summary of FDA's tissue-agnostic entrectinib indication and its gating conditions. No conflicting primary U.S. source was reviewed in this cycle.
  • external-beam radiation therapy (EBRT)[4]NCI PDQ: standard optionnot biomarker-selected in fetched NCI PDQ source; selected localized/regional, recurrent, unresectable/metastatic, or suspected microscopic residual RAI-refractory disease. · NCI PDQ notes there are no randomized trials guiding EBRT patient selection and that decisions are based on retrospective data and clinical judgment. This is not a claim that EBRT is needed or beneficial for every case. Confidence/conflicts: High for NCI PDQ treatment-option listing and caveat. No conflict identified.
  • external-beam radiation therapy (EBRT), palliative chemotherapy, and systemic therapy as appropriate by subtype[4]Standard option (per NCI PDQ)localized medullary, locally advanced/metastatic medullary, and anaplastic thyroid cancer contexts. · Palliative chemotherapy and EBRT are context-dependent and may be used for symptom relief or local control. This is not a personalized recommendation. Confidence/conflicts: high for NCI treatment-option listing; no conflict identified.
  • larotrectinib (Vitrakvi)[5]Standard option (per U.S. Food and Drug Administration)NTRK gene fusion; NTRK fusion-positive thyroid cancer in metastatic disease or surgery-morbid disease with no satisfactory alternative therapy or after progression on treatment. · This is a tissue-agnostic approval, not a thyroid-specific label page. Do not use it unless the thyroid tumor truly meets the NTRK-fusion and no-satisfactory-alternative or post-progression criteria. Confidence/conflicts: High for the tissue-agnostic U.S. larotrectinib indication and its gating criteria. No conflicting primary U.S. source was reviewed in this cycle.
  • palliative chemotherapy, clinical-trial search, palliative surgery/tracheostomy, EBRT, and selected targeted therapy context[6]NCI PDQ: standard optionRET mutation relevant for some targeted MTC options; BRAF V600E relevant for dabrafenib-trametinib in anaplastic thyroid cancer per NCI PDQ; metastatic medullary thyroid cancer; anaplastic thyroid cancer symptom-relief and systemic/local-control contexts. · This entry catalogs supportive and palliative options from NCI PDQ, not a recommendation to pursue any particular intervention. Goals of care, airway risk, symptom burden, mutation testing, and trial availability must be individualized. Confidence/conflicts: High for NCI PDQ supportive/palliative treatment-option listing. No conflict identified.
  • radioactive iodine therapy (RAI, iodine-131) and thyroid-suppression therapy[4]Standard option (per NCI PDQ)iodine uptake / iodine-sensitive disease context; localized/regional differentiated thyroid cancer; iodine-sensitive metastatic differentiated thyroid cancer. · NCI notes that if thyroidectomy is not done, RAI is not a treatment option for metastatic papillary or follicular thyroid cancer. RAI is not implied for medullary or anaplastic thyroid cancer. Confidence/conflicts: high for NCI treatment-option listing; no conflict identified.
  • radioactive iodine therapy (RAI; iodine-131)[4]NCI PDQ: standard optioniodine uptake / iodine-sensitive disease context rather than genomic biomarker; after surgery in selected localized/regional disease; iodine-sensitive metastatic papillary/follicular thyroid cancer. · RAI is not framed as appropriate for all thyroid cancers; NCI's patient summary separately states radioactive iodine is not used to treat medullary thyroid cancer. Individual appropriateness depends on histology, uptake, risk, prior treatment, and specialist evaluation. Confidence/conflicts: High for NCI PDQ treatment-option listing. No conflict identified.
  • repotrectinib (Augtyro)[7]FDA-approvedNTRK gene fusion; NTRK fusion-positive thyroid cancer in locally advanced, metastatic, or surgery-morbid disease after progression or when there is no satisfactory alternative therapy. · This is another tissue-agnostic approval. The source does not establish thyroid-subtype-specific sequencing, payer coverage, or routine use before standard thyroid-cancer-specific options are exhausted. Confidence/conflicts: High for the FDA repotrectinib tissue-agnostic indication and its entry criteria. No conflicting primary U.S. source was reviewed in this cycle.
  • selpercatinib (Retevmo)[8]FDA-approvedRET mutation detected by an FDA-approved test; advanced or metastatic RET-mutant medullary thyroid cancer requiring systemic therapy. · FDA indication requires RET mutation detected by an FDA-approved test and systemic-therapy need. This does not imply suitability for every RET-mutant case. Confidence/conflicts: high for FDA approval wording; no conflict identified.
  • surgery, including total thyroidectomy or lobectomy[4]Standard option (per NCI PDQ)localized/regional papillary and follicular thyroid cancer. · NCI PDQ is an evidence summary and does not determine individual surgical suitability or extent of surgery. Confidence/conflicts: high for NCI treatment-option listing; no conflict identified.
  • surgery: total thyroidectomy or lobectomy[4]NCI PDQ: standard optionnot biomarker-selected in fetched NCI PDQ source; localized/regional papillary and follicular thyroid cancer; primary local treatment. · NCI PDQ is an evidence summary, not an insurance coverage policy or individualized surgical recommendation. Extent of surgery depends on staging, anatomy, risk, and specialist evaluation. Confidence/conflicts: High for NCI PDQ treatment-option listing. No conflict identified.
  • targeted therapy / tyrosine kinase inhibitors; examples in NCI evidence include sorafenib, lenvatinib, cabozantinib, selpercatinib, and other targeted approaches depending on subtype and alteration[4]Standard option (per NCI PDQ)NCI notes actionable variants such as RET and NTRK gene fusions should be considered in advanced progressive disease; iodine-resistant metastatic differentiated thyroid cancer, recurrent differentiated thyroid cancer, locally advanced/metastatic medullary thyroid cancer, and anaplastic thyroid cancer systemic-therapy context. · Targeted therapy choice depends on subtype, progression, biomarker results, prior treatment, and approved label details. This finding does not rank drugs or imply eligibility. Confidence/conflicts: high for NCI treatment-option listing; no conflict identified.
  • trametinib (Mekinist) + dabrafenib (Tafinlar)[9]Standard option (per DailyMed / U.S. National Library of Medicine)BRAF V600E mutation; labelled efficacy evidence supporting the combination in locally advanced or metastatic BRAF V600E-positive ATC. · This is a single-arm label efficacy summary from Study BRF117019, not a head-to-head comparison against surgery, radiation, or chemotherapy. Confidence/conflicts: High for the exact label-reported ORR and response breakdown in the ATC cohort of Study BRF117019. No conflicting primary U.S. efficacy summary was reviewed in this cycle.

European Union

  • cabozantinib (Cabometyx)[10]EMA authorisedrefractory or not eligible to radioactive iodine; progressed during or after prior systemic therapy; after prior systemic therapy in locally advanced/metastatic DTC that is refractory or not eligible to RAI. · EMA central authorisation does not determine member-state reimbursement or sequencing access. Confidence/conflicts: high for EMA indication wording; no conflict identified.
  • cabozantinib (Cabometyx)[11]HAS reimbursement opinionnot biomarker-selected in fetched HAS summary; second-line and later after prior systemic treatment for progressive RAI-refractory or RAI-ineligible locally advanced/metastatic DTC. · HAS notes serious and grade >=3 adverse events in the evidence summary and lack of proven overall-survival gain in the cited analysis; local access and sequencing should be checked. Confidence/conflicts: High for HAS reimbursement summary. No conflict identified.
  • dabrafenib (Tafinlar) with trametinib (Mekinist)[12]EMA authorisedBRAF V600E mutation; locally advanced or metastatic BRAF V600E differentiated thyroid cancer after prior systemic therapy, RAI-refractory or not eligible. · This EMA indication is for differentiated thyroid cancer, not anaplastic thyroid cancer in the fetched EMA lines. Member-state reimbursement remains separate. Confidence/conflicts: high for EMA DTC indication wording; no EU ATC approval claim recorded because fetched EMA lines did not support it.
  • lenvatinib (Lenvima)[13]HAS reimbursement opinionnot biomarker-selected in fetched HAS source; adult differentiated thyroid carcinoma that is locally advanced or metastatic, RAI-refractory, and progressive. · The detailed opinion is a French-language HAS source and should receive human review before patient-facing reuse. It does not establish individual suitability, local stock, sequencing after other MKIs, or toxicity management. Confidence/conflicts: High for HAS indication/reimbursement context; French-language source requires human review. No conflict identified. Primary source not in English. English summary pending human review — confirm exact wording with your care team.
  • lenvatinib (Lenvima)[14]EMA authorisedradioactive iodine-refractory disease context; not genomic-biomarker selected; adult differentiated thyroid carcinoma that has progressed or spread locally/metastatically and does not respond to radioactive iodine. · EMA notes the medicine is prescription-only and treatment should be started and supervised by a doctor experienced with cancer medicines. The EPAR verifies EU authorisation, not member-state reimbursement or access in Germany/France. Confidence/conflicts: High for EU authorisation and indication category. No conflict identified.
  • lenvatinib (Lenvima); sorafenib (Nexavar)[14]EMA authorisedradioactive iodine refractory or not responsive context; no specific genomic biomarker required in fetched EMA lines; progressive or locally advanced/metastatic differentiated thyroid carcinoma that does not respond to or is refractory to radioactive iodine. · EMA central authorisation does not determine reimbursement or access in each member state. Germany/France HTA status remains a separate gap. Confidence/conflicts: high for EMA indication wording; no conflict identified.
  • multikinase inhibitor sequencing context: sorafenib (Nexavar), lenvatinib (Lenvima), then biomarker-directed selpercatinib (Retsevmo) question[15]HAS reimbursement opinionRET fusion is relevant for selpercatinib; no validated predictive biomarker for multikinase inhibitors in the fetched HAS discussion; systemic therapy strategy for adult advanced thyroid cancer requiring systemic treatment; specifically RAI-refractory DTC and RET fusion-positive advanced thyroid cancer after prior MKI treatment. · This is an HTA strategy summary from a French-language HAS opinion, not a current live clinical pathway or individualized sequencing recommendation. It should be human reviewed before reuse, and newer molecular/targeted decisions should be checked. Confidence/conflicts: Medium-high for 2021 HAS strategy summary; current pathway and later decisions unresolved. French-language source requires human review. Primary source not in English. English summary pending human review — confirm exact wording with your care team.
  • selpercatinib (Retsevmo)[16]EMA authorisedRET fusion or RET mutation; advanced thyroid cancer and advanced medullary thyroid cancer caused by RET alterations; prior-treatment details depend on the product information. · Retsevmo has conditional authorisation and long-term safety/effectiveness uncertainties remain under EMA follow-up. Exact RET alteration and prior-treatment criteria should be checked in the current SmPC and local reimbursement rules. Confidence/conflicts: medium-high for EMA authorisation overview; product-information detail remains a gap. No conflict identified.
  • selpercatinib (Retsevmo)[17]ApprovedRET gene fusion; validated test confirmation before treatment per G-BA resolution; after prior sorafenib and/or lenvatinib in advanced RET fusion-positive thyroid cancer requiring systemic therapy. · G-BA "additional benefit not proven" is not a statement that the drug is unavailable. It is a German benefit-assessment conclusion with legally binding German source text; the fetched English file is a courtesy translation. Confidence/conflicts: High for German HTA wording; no conflict identified. Courtesy-translation caveat applies.
  • selpercatinib (Retsevmo)[18]ApprovedRET mutation; validated test confirmation before treatment per G-BA resolution; first-line therapy for advanced RET-mutant MTC in adults/adolescents 12+. · The fetched resolution is marked repealed, so it should be used as historical HTA context only; current G-BA reassessment should be checked before patient-facing reuse. "Additional benefit not proven" is not a non-availability statement. Confidence/conflicts: Medium because the resolution is explicitly repealed; current German HTA status remains a gap. No conflicting current resolution fetched.
  • selpercatinib (Retsevmo)[19]HAS reimbursement opinionRET mutation; first-line treatment of advanced RET-mutant MTC in adults/adolescents 12+. · HAS reimbursement opinion does not guarantee centre-level access, sequencing decisions, or individual eligibility. The summary notes short follow-up and no demonstrated overall-survival improvement at interim analysis. Confidence/conflicts: High for HAS reimbursement summary. No conflict identified.
  • selpercatinib (Retsevmo)[15]ApprovedRET gene fusion; after prior sorafenib and/or lenvatinib in advanced RET fusion-positive thyroid cancer requiring systemic therapy. · This is a French-language HTA source and should receive human review. The entry intentionally distinguishes marketing-authorisation wording from the unfavorable HAS reimbursement conclusion; local early-access, compassionate-use, or later policy changes were not verified in this batch. Confidence/conflicts: Medium-high for 2021 HAS wording; possible later access-pathway changes remain unresolved. French-language source requires human review. Primary source not in English. English summary pending human review — confirm exact wording with your care team.
  • sorafenib (Nexavar)[20]HAS reimbursement opinionnot biomarker-selected in fetched HAS source; progressive locally advanced or metastatic differentiated thyroid carcinoma refractory to radioactive iodine; first-line context in the 2015 HAS opinion. · The detailed source is French-language and should receive human review. HAS noted no demonstrated overall-survival gain and quality-of-life deterioration in the evidence discussion, so this is a cataloged option rather than a preference statement. Confidence/conflicts: High for HAS opinion wording; French-language source requires human review. No conflict identified. Primary source not in English. English summary pending human review — confirm exact wording with your care team.
  • sorafenib (Nexavar)[21]EMA authorisedradioactive iodine-refractory disease context; not genomic-biomarker selected; progressive locally advanced or metastatic differentiated thyroid carcinoma refractory to radioactive iodine. · EMA verifies EU marketing authorisation and indication wording. The source does not establish local reimbursement, sequencing against lenvatinib/cabozantinib, or access in a specific member state. Confidence/conflicts: High for EU indication wording. No conflict identified.
  • vandetanib (Caprelsa)[22]EMA authorisedRET mutation status relevant; EMA states possible lower benefit should be considered when RET mutation is unknown or negative; aggressive and symptomatic MTC with unresectable locally advanced or metastatic disease. · EMA verifies EU authorisation and highlights RET-status uncertainty. National reimbursement can differ, and the EPAR page is not a personalized eligibility statement. Confidence/conflicts: High for EMA indication wording and RET caveat. No conflict identified.
  • vandetanib (Caprelsa); cabozantinib (Cometriq)[22]EMA authorisedRET mutation status should be checked; EMA notes possible lower benefit when RET mutation is not known or is negative; aggressive symptomatic unresectable locally advanced/metastatic MTC for Caprelsa; unresectable progressed or metastatic MTC for Cometriq. · Caprelsa has conditional approval and QTc-risk measures; RET mutation-negative/unknown cases may have lower benefit. Cometriq has conditional approval and dose/side-effect considerations. Member-state reimbursement remains separate. Confidence/conflicts: high for EMA indication wording; no conflict identified.

United Kingdom

  • Cabozantinib (Cabometyx)[23]ApprovedRadioactive-iodine unsuitable or refractory; no gene biomarker specified; Negative NICE funding recommendation after systemic treatment for locally advanced or metastatic differentiated thyroid cancer unsuitable for or refractory to radioactive iodine. · This is a verified negative availability/funding cell, not a recommendation to use cabozantinib. NICE describes standard treatment in this setting as best supportive care and states cabozantinib was not recommended because survival benefit and cost-effectiveness were uncertain. Confidence/conflicts: High for negative NICE England-context recommendation; no conflict in fetched NICE page.
  • Cabozantinib (Cometriq)[24]ApprovedRET mutation status may affect benefit discussion according to marketing-authorisation summary; recommendation is not restricted to RET-positive disease in NICE TA516; Progressive medullary thyroid cancer in adults with unresectable, locally advanced or metastatic disease. · NICE guidance is England NHS context and depends on marketing authorisation and patient access scheme. NICE's information page notes lower possible benefit should be considered where RET mutation status is unknown or negative. Confidence/conflicts: High for NICE England-context recommendation; no conflict in fetched NICE pages.
  • Lenvatinib (Lenvima); sorafenib (Nexavar)[25]NICE recommendedRadioactive-iodine refractory; no gene biomarker specified; Progressive, locally advanced or metastatic differentiated thyroid cancer after radioactive iodine, in adults, with the tyrosine-kinase-inhibitor restrictions stated by NICE. · NICE technology appraisals are England NHS funding guidance; devolved-nation funding may differ. NICE explicitly limits use by prior tyrosine kinase inhibitor exposure/tolerability and commercial-arrangement conditions. Confidence/conflicts: High for NICE England-context recommendation; no conflict in fetched NICE pages.
  • Selpercatinib (Retsevmo)[26]NICE recommendedRET fusion-positive thyroid cancer; RET-mutant medullary thyroid cancer; Untreated with a targeted cancer drug under TA1039; after sorafenib or lenvatinib for RET fusion-positive thyroid cancer, or after cabozantinib or vandetanib for RET-mutant medullary thyroid cancer, under TA1038. · NICE guidance is England NHS context and depends on RET alteration, age, prior targeted therapy status, radioactive-iodine context where appropriate, and commercial arrangements. NICE notes uncertainty in indirect comparisons in the TA1039 rationale. Confidence/conflicts: High for NICE recommendation and sequencing; uncertainty in comparative magnitude is noted by NICE, not a source conflict.
  • Surgery; hormone therapy; radioactive iodine treatment; targeted medicines; radiotherapy; chemotherapy; palliative care / symptom-control team support[27]Standard option (per NHS)Surgery is described as common treatment; radioactive iodine may be used after surgery or if cancer has come back or spread; targeted medicines may be used if other treatments are not an option or no longer working and cancer has spread; radiotherapy may be used if cancer cannot be removed by surgery or has spread; chemotherapy is not usually used but may be used if cancer has come back or spread; palliative/symptom-control care is described for advanced thyroid cancer when cure may not be possible. · NHS guidance is broad patient-facing UK guidance and does not establish which targeted medicine, regimen, local formulary, or devolved-nation funding route applies. It frames treatment choice as dependent on cancer size/type, spread, and general health, with the specialist team explaining benefits and side effects. Confidence/conflicts: High for broad UK NHS category listing; no conflict found in fetched source.
  • Vandetanib (Caprelsa)[28]ApprovedNegative NICE funding recommendation for aggressive and symptomatic medullary thyroid cancer in adults with unresectable, locally advanced or metastatic disease. · This is a verified negative availability/funding cell, not a recommendation to use vandetanib. NICE is England NHS context; existing treatment before publication may continue under NICE's stated caveat, and devolved-nation policies may differ. Confidence/conflicts: High for negative NICE England-context recommendation; no conflict in fetched NICE pages.
  • lenvatinib (Lenvima) and sorafenib (Nexavar)[25]NICE recommendednot biomarker-selected in fetched NICE source; after radioactive iodine; progressive locally advanced/metastatic RAI-refractory DTC; TKI-naive or early TKI stop because of toxicity. · NICE recommendations apply to England/Wales commissioning context and include commercial-arrangement conditions. NICE says the recommendation is not meant to affect people already receiving treatment outside the recommendation before guidance publication. Confidence/conflicts: High for NICE recommendation wording. No conflict identified.
  • palliative care team / symptom control team support[27]Standard option (per NHS)not biomarker-selected in fetched source; advanced thyroid cancer when cure may not be possible and symptom-control support is needed alongside cancer-directed treatment. · This is broad NHS supportive-care guidance and should not be read as a statement about prognosis in any individual case. Confidence/conflicts: High for the NHS referral and symptom-control wording in advanced thyroid cancer. No conflicting U.K. primary source was reviewed in this cycle.
  • radioactive iodine treatment[27]Standard option (per NHS)radioactive-iodine-sensitive context implied; no gene biomarker specified; adjuvant post-surgical use or recurrent/metastatic disease when radioactive iodine is considered appropriate. · The NHS page does not define which thyroid-cancer subtypes are expected to benefit, nor does it specify dose, preparation, or refractory criteria. Confidence/conflicts: High for the exact NHS use-cases stated for radioactive iodine in thyroid cancer. No conflicting U.K. primary source was reviewed in this cycle.
  • radiotherapy[27]Standard option (per NHS)not biomarker-selected in fetched source; unresectable local disease or metastatic spread requiring radiotherapy. · This broad NHS page does not distinguish external-beam, palliative, or subtype-specific radiotherapy use, and it does not specify dose or sequencing with surgery or systemic therapy. Confidence/conflicts: High for the broad NHS radiotherapy-use wording. No conflicting U.K. primary source was reviewed in this cycle.
  • thyroid hormone tablets[27]Standard option (per NHS)not biomarker-selected in fetched source; post-thyroidectomy or post-partial-thyroidectomy hormone replacement and recurrence-risk management context. · The page is patient-facing and does not specify the exact drug, dose targets, TSH-suppression strategy, or how practice differs by histology and recurrence risk. Confidence/conflicts: High for the NHS statement that hormone tablets are usually needed after thyroid removal and may also reduce recurrence risk. No conflicting U.K. primary source was reviewed in this cycle.
  • thyroid surgery (total thyroidectomy, partial thyroidectomy, or lobectomy)[27]Standard option (per NHS)not biomarker-selected in fetched source; initial local treatment planning according to thyroid-cancer type, stage, and possible neck-node spread. · This is broad NHS treatment guidance and does not define histology-specific operative thresholds, extent-of-surgery criteria, or devolved-nation referral differences. Confidence/conflicts: High for the broad NHS surgery-pathway wording. No conflicting U.K. primary source was reviewed in this cycle.

Japan

  • Encorafenib (Braftovi) + binimetinib (Mektovi)[29]PMDA-approved (Japan)BRAF mutation-positive; Unresectable BRAF mutation-positive thyroid cancer after cancer chemotherapy; unresectable BRAF mutation-positive anaplastic thyroid cancer. · The PMDA list does not specify all label details, exact companion diagnostic requirements, reimbursement, or whether "thyroid cancer" excludes anaplastic in the first listed indication; it lists anaplastic thyroid cancer separately. Confidence/conflicts: High for PMDA approval-list entry; label-detail gap remains.
  • Lenvatinib mesilate (Lenvima)[29]PMDA-approved (Japan)Unresectable thyroid cancer. · The PMDA list is an approval ledger and does not provide full Japanese package-insert criteria, reimbursement status, sequencing, or subtype-specific guidance in the fetched lines. Confidence/conflicts: High for PMDA approval-list entry; label-detail gap remains.
  • RET gene mutation analysis[30]Standard option (per Endocrine Journal / Japan Endocrine Society / J-STAGE)RET gene mutation; diagnostic and treatment-planning workup for medullary thyroid carcinoma. · This is clinical-guideline testing advice, not a payer-coverage or laboratory-availability statement. The source also notes that genetic testing results can trigger psychological reactions and that pheochromocytoma must be diagnosed or ruled out when hereditary disease is identified. Confidence/conflicts: High for the guideline recommendation that RET analysis be performed for all MTC patients and for the >98% hereditary-case detection statement. No conflicting Japan primary source was reviewed in this cycle.
  • Selpercatinib (Retevmo)[29]PMDA-approved (Japan)RET fusion gene-positive thyroid cancer; RET gene mutation-positive medullary thyroid cancer; RET fusion gene-positive unresectable thyroid cancer; RET gene mutation-positive unresectable medullary thyroid cancer; broader RET fusion gene-positive advanced or recurrent solid tumor indication noted separately. · The PMDA list supports approval status but not full sequencing, prior-therapy requirements, companion diagnostic details, or reimbursement status in the fetched lines. Confidence/conflicts: High for PMDA approval-list entries; label-detail gap remains.
  • Sorafenib tosilate (Nexavar)[29]PMDA-approved (Japan)Unresectable thyroid cancer. · The PMDA list does not provide complete current label wording, sequencing, reimbursement, or subtype-specific criteria in the fetched lines. Confidence/conflicts: High for PMDA approval-list entry; label-detail gap remains.
  • Vandetanib (Caprelsa)[29]PMDA-approved (Japan)Unresectable medullary thyroid cancer. · The PMDA list does not provide full Japanese package-insert safety restrictions, ECG/QTc monitoring requirements, reimbursement status, or current clinical positioning in the fetched lines. Confidence/conflicts: High for PMDA approval-list entry; label-detail gap remains.
  • active surveillance[30]Standard option (per Endocrine Journal / Japan Endocrine Society / J-STAGE)very low-risk T1aN0M0; no molecular biomarker gating in the fetched source; initial management of very low-risk papillary thyroid carcinoma before immediate surgery. · This is Japan guideline pathway advice, not a regulator approval or reimbursement statement. The same source says active surveillance requires reliable ultrasound follow-up once or twice yearly and excludes tumors with clinical nodal disease, distant metastasis, apparent extrathyroidal extension, or high-risk proximity to the trachea, esophagus, or recurrent laryngeal nerve. Confidence/conflicts: High for the Japanese guideline recommendation and surveillance-progression percentages. No conflicting Japan primary guideline was reviewed in this cycle.
  • early palliative care and holistic best supportive care[30]Standard option (per Endocrine Journal / Japan Endocrine Society / J-STAGE)no biomarker gating in the fetched source; from diagnosis onward in anaplastic thyroid carcinoma, alongside or instead of anticancer therapy depending on response and condition. · The guideline explicitly says direct published evidence demonstrating the usefulness of palliative care in ATC is lacking, so this is a strong expert-consensus pathway recommendation rather than a trial-backed survival claim. It must not be reframed as a prognosis statement for any individual person. Confidence/conflicts: High for the guideline's strong recommendation for early palliative and best supportive care in ATC, with the caveat that this is expert-consensus guidance rather than direct trial evidence. No conflicting Japan primary source was reviewed in this cycle.
  • lenvatinib (Lenvima)[31]PMDA-approved (Japan)not biomarker-selected in fetched PMDA source; unresectable/radically unresectable thyroid cancer in the PMDA sources; histology and prior-treatment details require current Japanese label review. · The fetched PMDA review report was for a later thymic-carcinoma partial-change application but explicitly summarizes the existing thyroid-cancer approval. It is an English reference translation; the Japanese original prevails if inconsistent. Current reimbursement and exact e-label wording remain unresolved. Confidence/conflicts: High for PMDA approval/launch and indication category; exact current Japanese e-label details unresolved. No conflict identified.
  • multidisciplinary treatment including palliative surgery, radiotherapy, and chemotherapy as appropriate[30]Approvedno biomarker gating in the fetched source; unresectable locally advanced or metastatic anaplastic thyroid carcinoma requiring urgent multimodality planning. · The same guideline says chemotherapy has not been shown to control distant metastasis reliably, multimodal benefit is limited overall, and serious adverse events can impair quality of life. This is not a reimbursement statement and does not settle local center capability. Confidence/conflicts: High for the Japanese guideline recommendation for unresectable-ATC multidisciplinary treatment and for the response-rate ranges it cites. No conflicting Japan primary source was reviewed in this cycle.
  • postoperative radioactive iodine (RAI) therapy[30]Standard option (per Endocrine Journal / Japan Endocrine Society / J-STAGE)no molecular biomarker gating in the fetched source; risk class and histology determine use; postoperative risk-adapted radioactive-iodine planning in differentiated thyroid carcinoma. · This is Japan guideline pathway detail, not proof of room capacity or center scheduling. The same source warns that historical Japanese resource limits sometimes blurred the distinction between ablation and adjuvant therapy and lists acute gastrointestinal symptoms and radiation sialadenitis in 60% to 70% of patients. Confidence/conflicts: High for the risk-adapted Japanese RAI recommendations and the source-stated toxicity caveat. No conflicting Japan primary guideline was reviewed in this cycle.
  • risk-adapted surgery, radioactive iodine therapy, and thyrotropin suppression therapy[32]Standard option (per Endocrine Journal / Japan Endocrine Society / J-STAGE)iodine uptake / RAI suitability context rather than genomic biomarker; initial management of papillary thyroid carcinoma by Japanese risk categories; RAI for selected high-risk/intermediate-risk and selected persistent/metastatic DTC contexts. · This is a peer-reviewed English review of Japanese guideline practice and RAI availability, not the guideline PDF itself or a payer document. The source emphasizes facility/wait-time constraints and limited dedicated RAI resources in Japan. Confidence/conflicts: Medium-high for Japanese guideline-pathway description; direct 2024 revised guideline details remain a gap. No conflict identified.
  • sorafenib (Nexavar)[33]PMDA-approved (Japan)not biomarker-selected in fetched PMDA source; radically unresectable thyroid cancer; exact histology, RAI-refractory, and sequencing wording were not available in the fetched source. · The PMDA source is a safety-information table, not a full current package insert. It verifies the Japan indication category but not reimbursement, current label nuance, or sequencing with lenvatinib/cabozantinib/RET inhibitors. Confidence/conflicts: Medium-high for indication category from PMDA; current full label unresolved. No conflict identified.
  • vandetanib (Caprelsa)[33]PMDA-approved (Japan)RET status not specified in fetched PMDA source; radically unresectable medullary thyroid cancer. · The PMDA attachment verifies launch and indication category but is not the full current Japanese package insert. It does not establish RET testing requirements, reimbursement, or sequencing relative to cabozantinib or RET-selective inhibitors. Confidence/conflicts: Medium-high for indication category from PMDA; current full label unresolved. No conflict identified.

Korea

  • lenvatinib mesylate (Lenvima)[34]MFDS-approved (Korea)radioactive iodine-refractory disease context; not genomic-biomarker selected; first-line therapy for unresectable, RAI-nonresponsive locally advanced or metastatic differentiated thyroid cancer, per the fetched article. · This is a Korean-language secondary/news source reporting Eisai Korea and MFDS/HIRA-related status, not a directly fetched MFDS label or HIRA reimbursement notice. Direct MFDS and current reimbursement criteria remain gaps. Confidence/conflicts: Medium because the fetched source reports approval and reimbursement but is not the primary MFDS/HIRA record. No conflict identified. Primary source is in Korean. English summary pending human review — confirm exact wording with your care team.
  • selpercatinib (Retevmo)[35]EMA authorisedRET-mutant; advanced or metastatic RET-mutant MTC requiring systemic therapy in adults and pediatric patients age 12 years and older. · Approval is supported by fetched Korean secondary/manufacturer-reporting sources, not direct MFDS label fetch. Reimbursement/access is uncertain: Korea Biomedical Review reported uninsured status, while later Korean reporting described renewed reimbursement efforts. Current national reimbursement status needs direct HIRA confirmation. Confidence/conflicts: Medium. Sources agree on MFDS approval but reimbursement status is evolving and must be confirmed against current HIRA records. Primary source is in Korean. English summary pending human review — confirm exact wording with your care team.

China

  • pralsetinib (Gavreto)[36]NMPA-approved (China)RET mutation; advanced or metastatic RET-mutant MTC requiring systemic therapy in adults and pediatric patients 12+. · This is a company release citing NMPA approval, not a direct NMPA label page. The source does not establish reimbursement, hospital formulary status, individual eligibility, or molecular testing coverage. Confidence/conflicts: Medium-high for NMPA approval claim because the source directly cites NMPA but is not the regulator's own page. No conflict identified.
  • selpercatinib (brand not specified in fetched China announcement; Retevmo referenced globally)[37]ApprovedRET mutation; advanced or metastatic RET-mutant MTC requiring systemic therapy in adults and pediatric patients 12+. · This is a company announcement citing NMPA approval, not a direct NMPA label page. Pricing, import/distribution timing, hospital access, reimbursement, and testing access are not established by the fetched source. Confidence/conflicts: Medium-high for NMPA approval claim because the source directly cites NMPA but is not the regulator's own page. No conflict identified.

Russia

  • Dabrafenib plus trametinib, larotrectinib, entrectinib, paclitaxel/carboplatin, doxorubicin/docetaxel, paclitaxel, or doxorubicin[38]ApprovedBRAF V600E mutation for dabrafenib/trametinib; NTRK fusion for larotrectinib or entrectinib; Systemic therapy or radiosensitizing treatment for anaplastic thyroid cancer; biomarker-directed options when BRAF V600E or NTRK alteration is present. · Requires rapid histologic and molecular confirmation. Commission decision, drug availability, urgency of airway/local control, and performance status are central; direct label/reimbursement status was not verified in this batch. Confidence/conflicts: Medium-high because RUSSCO lists options, but urgent local feasibility and authorization details are not established. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
  • Thyroid surgery, radioactive iodine (I-131) diagnostic/treatment pathway, and TSH-suppressive therapy/observation in selected stable radioiodine-refractory disease[38]Standard option (per Russian Society of Clinical Oncology / RosOncoWeb)Histology and stage; radioiodine avidity/refractoriness later guide treatment; Primary treatment; post-surgical radioiodine-sensitive metastatic differentiated thyroid cancer; stable radioiodine-refractory follow-up. · Surgical extent, radioiodine use, and observation vs systemic therapy depend on histology, stage, iodine uptake, TSH stimulation/scanning adequacy, RECIST progression, symptoms, and feasibility of thyroidectomy. Confidence/conflicts: High for RUSSCO framework; Russian-language clinical text needs human review before patient-facing reuse. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
  • Vandetanib (Caprelsa-class), selpercatinib (Retevmo-class), and cabozantinib in second-line targeted therapy by commission decision[38]Standard option (per Russian Society of Clinical Oncology / RosOncoWeb)RET mutation status guides preferred selpercatinib option in source; Systemic treatment for progressive unresectable locally advanced or metastatic medullary thyroid cancer; second-line targeted therapy context. · Requires RET testing where relevant and assessment of symptoms/structural progression. Access and reimbursement are not confirmed. Confidence/conflicts: High for guideline inclusion; direct regulator/payer status remains unresolved. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
  • lenvatinib (Lenvima / lenvatinib)[39]Approvedradioactive iodine-refractory disease context; not genomic-biomarker selected; progressive differentiated thyroid cancer refractory to radioactive iodine. · RLS is a Russian drug-reference source, not the official GRLS registry page. The source verifies Russian-language drug-reference indication text but not current state registration status, reimbursement, procurement, or regional access. Confidence/conflicts: Medium because indication text is supported by a fetched Russian drug-reference page, while direct GRLS confirmation remains unresolved. No conflict identified. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
  • selpercatinib (Retevmo / Retsevmo transliteration)[40]ApprovedRET mutation context for MTC; source describes RET-mutant disease for selpercatinib; advanced RET-mutant MTC and RET fusion-positive thyroid cancer; exact Russian label wording requires direct registry review. · This is a Russian oncology-association page, not the official regulator registry or product instruction. It supports a registration/access signal but should be checked against GRLS and current procurement/reimbursement pathways. Confidence/conflicts: Medium. Sources support RET-altered thyroid/MTC clinical indication context and a registration signal; direct GRLS regulator record remains unresolved. No conflict identified. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
  • sorafenib (Nexavar / sorafenib)[41]Approvedradioactive iodine-refractory disease context; not genomic-biomarker selected; locally recurrent or metastatic progressive differentiated thyroid carcinoma refractory to radioactive iodine. · RLS is a drug-reference source rather than the official GRLS registry. The entry does not establish current reimbursement, procurement, or regional availability. Confidence/conflicts: Medium because a Russian drug-reference source supports the indication, but direct GRLS confirmation remains unresolved. No conflict identified. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
  • vandetanib (Caprelsa)[42]Approvednot biomarker-selected in fetched Russian registration article; unresectable locally advanced or metastatic medullary thyroid cancer. · This is an oncology news report of Russian registration, not the official GRLS product record. Current registration holder, supply, reimbursement, and label changes need direct verification. Confidence/conflicts: Medium-low for current availability because the registration report is old and direct GRLS confirmation remains unresolved; medium for historical Russia registration signal. No conflict identified. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.

Thailand

  • Cabozantinib (Cabometyx)[43]ApprovedNot biomarker-selected in source; Post-prior-systemic-therapy locally advanced/metastatic DTC, refractory or not eligible to radioiodine. · This batch did not verify Thai labels for lenvatinib or sorafenib in DTC, which are often earlier-line comparators in other jurisdictions. Reimbursement and sequencing after prior systemic therapy remain gaps. Confidence/conflicts: High for Thai NDI Cabometyx indication text; earlier-line Thai DTC targeted therapy remains unverified.
  • Dabrafenib (Tafinlar) plus trametinib (Mekinist)[44]ApprovedBRAF V600E mutation; Unresectable or metastatic BRAF V600E-mutated solid tumor after prior treatment when no satisfactory alternatives exist; thyroid-specific use should be confirmed clinically. · This is not a thyroid-specific Thai indication in the fetched wording. BRAF V600E must be confirmed by a validated test, and colorectal cancer is excluded in the source. Reimbursement and thyroid-specific access are not established. Confidence/conflicts: Medium-high; Thai NDI supports tumor-agnostic BRAF V600E solid-tumor indication, but thyroid-specific indication and reimbursement require follow-up.
  • Pralsetinib (Gavreto)[45]ApprovedRET gene mutation for MTC; RET gene fusion for thyroid cancer; radioactive-iodine refractory status if radioiodine is appropriate; Systemic therapy for RET-mutant MTC or RET fusion-positive thyroid cancer in adults/pediatric patients 12+. · Patient selection should be based on a validated RET test. This label-backed record does not establish reimbursement, hospital formulary availability, or choice between RET inhibitors. Confidence/conflicts: High for Thai NDI indication text; access not established.
  • Selpercatinib (Tanstrive / Retevmo-class)[46]ApprovedRET gene fusion for non-medullary thyroid cancer; RET mutation for medullary thyroid cancer; RET fusion-positive advanced thyroid cancer after prior sorafenib and/or lenvatinib; RET-mutant advanced medullary thyroid cancer in adults/adolescents 12+. · A validated RET fusion or mutation test is required by the source. NDI supports label wording but not reimbursement, availability, pediatric center capability, or whether prior sorafenib/lenvatinib was accessible. Confidence/conflicts: High for Thai NDI indication text; access and reimbursement not established.
  • cabozantinib (Cabometyx)[47]Approvednot biomarker-selected in fetched Thai NDI-hosted source; after prior systemic therapy for adult locally advanced/metastatic RAI-refractory or RAI-ineligible DTC. · NDI registration/SmPC support does not confirm reimbursement, NLEM inclusion, hospital formulary availability, or sequencing after lenvatinib/sorafenib. The NDI registration pages are Thai-language and should receive human review. Confidence/conflicts: High for NDI registration and DTC indication in the SmPC; reimbursement unresolved. No conflict identified. Primary source is in Thai. English summary pending human review — confirm exact wording with your care team.
  • selpercatinib (Tanstrive)[46]ApprovedRET fusion for advanced thyroid cancer; RET mutation for medullary thyroid cancer; RET testing described in the fetched label; RET fusion-positive thyroid cancer after prior sorafenib and/or lenvatinib; advanced RET-mutant MTC in adults/adolescents 12+. · The source verifies an NDI-hosted label, not reimbursement or test availability. RET testing method, local molecular-pathology access, and payer access are unresolved. Confidence/conflicts: High for NDI-hosted label indication; reimbursement and molecular-testing pathway unresolved. No conflict identified.
  • sorafenib (Infenib; Nexavar registration also identified)[48]Approvednot biomarker-selected in fetched Thai NDI-hosted source; progressive locally advanced or metastatic DTC refractory to radioactive iodine. · This records Thai NDI-hosted product information and registration data, not reimbursement, NLEM inclusion, hospital formulary access, or individual suitability. The NDI source is partly Thai-language and should receive human review for patient-facing reuse. Confidence/conflicts: High for Thai NDI-hosted Infenib indication and Nexavar registration; reimbursement unresolved. No conflict identified. Primary source is in Thai. English summary pending human review — confirm exact wording with your care team.

출처

  1. DailyMed / U.S. National Library of Medicine — official U.S. drug label · official U.S. drug label
  2. U.S. Food and Drug Administration (FDA) — orphan drug designation and approvals listing · orphan drug designation and approvals listing
  3. National Cancer Institute — national cancer agency FDA approval summary · national cancer agency FDA approval summary
  4. National Cancer Institute (NCI) / PDQ Adult Treatment Editorial Board — national cancer agency evidence summary · national cancer agency evidence summary
  5. U.S. Food and Drug Administration — regulator approval notice · regulator approval notice
  6. National Cancer Institute (NCI) / PDQ Adult Treatment Editorial Board — national cancer agency patient evidence summary · national cancer agency patient evidence summary
  7. U.S. Food and Drug Administration — regulator approval notice · regulator approval notice
  8. U.S. Food and Drug Administration (FDA) — regulator approval notice · regulator approval notice
  9. DailyMed / U.S. National Library of Medicine — official U.S. drug label · official U.S. drug label
  10. European Medicines Agency (EMA) — regulator EPAR · regulator EPAR
  11. Haute Autorite de Sante (HAS) — Transparency Committee drug opinion / reimbursement summary · Transparency Committee drug opinion / reimbursement summary
  12. European Medicines Agency (EMA) — regulator EPAR · regulator EPAR
  13. Haute Autorite de Sante (HAS) — medicine page / HTA summary · medicine page / HTA summary
  14. European Medicines Agency (EMA) — EPAR regulator medicine page · EPAR regulator medicine page
  15. Haute Autorite de Sante (HAS) — Transparency Committee drug opinion PDF / strategy summary · Transparency Committee drug opinion PDF / strategy summary
  16. European Medicines Agency (EMA) — regulator EPAR · regulator EPAR
  17. Gemeinsamer Bundesausschuss (G-BA) — benefit-assessment resolution / HTA reimbursement decision · benefit-assessment resolution / HTA reimbursement decision
  18. Gemeinsamer Bundesausschuss (G-BA) — benefit-assessment resolution / HTA reimbursement decision · benefit-assessment resolution / HTA reimbursement decision
  19. Haute Autorite de Sante (HAS) — Transparency Committee drug opinion / reimbursement summary · Transparency Committee drug opinion / reimbursement summary
  20. Haute Autorite de Sante (HAS) — Transparency Committee drug opinion PDF · Transparency Committee drug opinion PDF
  21. European Medicines Agency (EMA) — EPAR regulator medicine page · EPAR regulator medicine page
  22. European Medicines Agency (EMA) — EPAR regulator medicine page · EPAR regulator medicine page
  23. NICE — technology appraisal guidance · technology appraisal guidance
  24. NICE — technology appraisal guidance · technology appraisal guidance
  25. NICE — technology appraisal guidance · technology appraisal guidance
  26. NICE — technology appraisal guidance · technology appraisal guidance
  27. NHS — national health service patient treatment guidance · national health service patient treatment guidance
  28. NICE — technology appraisal guidance · technology appraisal guidance
  29. Pharmaceuticals and Medical Devices Agency (PMDA) — regulator approved-drug list · regulator approved-drug list
  30. Endocrine Journal / Japan Endocrine Society / J-STAGE — translated clinical-practice-guideline full-text HTML · translated clinical-practice-guideline full-text HTML
  31. Pharmaceuticals and Medical Devices Agency (PMDA) / MHLW — review report PDF · review report PDF
  32. Endocrine Journal / Japan Endocrine Society / J-STAGE — translated clinical-practice-guideline article · translated clinical-practice-guideline article
  33. Pharmaceuticals and Medical Devices Agency (PMDA) — safety-information attachment with launch/indication table · safety-information attachment with launch/indication table
  34. Healtho Korea — Korean health-news article reporting MFDS approval and insurance reimbursement · Korean health-news article reporting MFDS approval and insurance reimbursement
  35. eMD Medical News — Korean medical-news article reporting MFDS approval/manufacturer announcement · Korean medical-news article reporting MFDS approval/manufacturer announcement
  36. CStone Pharmaceuticals — manufacturer approval announcement citing NMPA · manufacturer approval announcement citing NMPA
  37. Innovent Biologics via PR Newswire — manufacturer approval announcement citing NMPA · manufacturer approval announcement citing NMPA
  38. Russian Society of Clinical Oncology (RUSSCO) / RosOncoWeb — professional society clinical recommendations PDF · professional society clinical recommendations PDF
  39. RLS / Register of Medicines of Russia drug-reference site — Russian drug-reference substance page · Russian drug-reference substance page
  40. Russian oncology association website — Russian oncology-association access/registration article · Russian oncology-association access/registration article
  41. RLS / Register of Medicines of Russia drug-reference site — Russian drug-reference substance page · Russian drug-reference substance page
  42. RUSSCO / RosOncoWeb — Russian oncology news report of Russian registration · Russian oncology news report of Russian registration
  43. Thai National Drug Information / Thai FDA-MOPH — prescribing information PDF / regulator drug-information repository · prescribing information PDF / regulator drug-information repository
  44. Thai National Drug Information / Thai FDA-MOPH — prescribing information PDF / regulator drug-information repository · prescribing information PDF / regulator drug-information repository
  45. Thai National Drug Information / Thai FDA-MOPH — prescribing information PDF / regulator drug-information repository · prescribing information PDF / regulator drug-information repository
  46. Thai National Drug Information / Thai FDA-MOPH — prescribing information PDF / regulator drug-information repository · prescribing information PDF / regulator drug-information repository
  47. Thai National Drug Information / Thai FDA-MOPH — drug registration record · drug registration record
  48. Thai National Drug Information / Thai FDA-MOPH — NDI-hosted prescribing information PDF · NDI-hosted prescribing information PDF

위 내용은 공식 규제·접근 상태일 뿐, 의학적 조언이나 추천이 아니고, 적격성을 판단하지도 않습니다. 어떤 선택지가 적합한지는 환자의 상황과 종양내과 팀에 달려 있습니다. 규제 상태는 바뀔 수 있으니 표시된 출처에서 확인하세요. 일부 선택지는 신속·조건부 승인 상태로, 적응증이 축소되거나 철회될 수 있습니다. 임상 세부 내용은 영문이 정본입니다. 최종 확인 2026.06.

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임상시험이나 초기 보고에 실렸다는 것은 해당 선택지가 연구되고 있다는 의미일 뿐, 효과가 있거나 특정 환자에게 안전하거나 현재 등록 가능하다는 뜻은 아닙니다. 어떤 선택지가 적합한지는 담당 종양내과 팀과 임상시험 팀이 함께 상의할 문제입니다. 최종 확인 2026.06.

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진료 전 정리할 정보

  • Is lobectomy or total thyroidectomy being considered, and why?
  • Are lymph nodes involved or suspected?
  • How would surgery affect later radioactive iodine or thyroid-hormone planning?
  • Does the cancer take up radioactive iodine?

임상시험 검색어

Thyroid cancer clinical trial