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Renal cell carcinoma (kidney cancer): 국가별 선택지

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선택지 정리됨고형암최종 확인 2026.06

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Renal cell carcinoma (kidney cancer) clinical trial

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

  • belzutifan (Welireg)[1]FDA-approvedHIF-2alpha pathway targeted by drug class; no tumor biomarker test requirement stated in the FDA approval notice; after prior PD-1/PD-L1 inhibitor and prior VEGF-TKI. · FDA approval does not define individual sequencing beyond the prior-therapy requirement. Hypoxia/anemia and other label-specific risks require current prescribing-information review. Confidence/conflicts: high for FDA approval wording; no conflict identified.
  • immune checkpoint combinations and targeted combinations, including ipilimumab+nivolumab, pembrolizumab+axitinib, pembrolizumab+lenvatinib, nivolumab+cabozantinib, avelumab+axitinib[2]Standard option (per NCI PDQ)first-line stage IV renal cell cancer; risk group specified by NCI for ipilimumab+nivolumab and cabozantinib monotherapy. · Regimen selection depends on histology, risk group, autoimmune history, comorbidities, drug interactions, blood pressure, organ function, and prior therapy. NCI PDQ does not rank these for an individual patient. Confidence/conflicts: high for NCI option listing; no conflict identified.
  • partial nephrectomy, radical nephrectomy, simple nephrectomy, cytoreductive nephrectomy, palliative nephrectomy[2]Standard option (per NCI PDQ)stage I-III localized/locally advanced disease; selected stage IV first-line local therapy contexts. · NCI PDQ is an evidence summary, not an individualized surgical plan. Surgical feasibility depends on stage, kidney function, contralateral kidney status, metastatic burden, performance status, and patient goals. Confidence/conflicts: high for NCI stage-based option listing; no conflict identified.
  • pembrolizumab (Keytruda)[3]FDA-approvedadjuvant treatment after nephrectomy or after nephrectomy plus resection of metastatic lesions. · FDA notice states a risk-of-recurrence population; it does not imply all post-nephrectomy patients qualify. Recurrence-risk category, pathology, recovery, autoimmune history, and surveillance strategy matter. Confidence/conflicts: high for FDA approval wording; no conflict identified.
  • pembrolizumab (Keytruda) plus axitinib (Inlyta)[4]FDA-approvedfirst-line advanced renal cell carcinoma. · FDA approval does not establish individual suitability. Immune-related risks, hypertension, bleeding/thrombosis, hepatic effects, and other axitinib or pembrolizumab safety considerations require current label review and oncology judgment. Confidence/conflicts: high for FDA approval wording; no conflict identified.
  • stereotactic ablative body radiation therapy / stereotactic body radiation therapy (SABR/SBRT) and external-beam radiation therapy (EBRT)[2]Standard option (per NCI PDQ)stage I local treatment option; selected perioperative and palliative contexts; stage IV palliative context. · Radiation intent and suitability vary by tumor site, symptoms, kidney function, prior surgery, and metastatic sites. This entry does not specify dose or fractionation. Confidence/conflicts: high for NCI option listing; no conflict identified.

European Union

  • belzutifan (Welireg)[5]EMA authorisedVHL disease for the associated-tumour indication; prior PD-(L)1 and VEGF-targeted therapy sequence for advanced clear cell RCC; advanced clear cell RCC after two or more prior lines including PD-(L)1 and at least two VEGF-targeted therapies; VHL-associated localised RCC when local procedures are unsuitable. · Conditional authorisation means EMA is monitoring additional data. Member-state reimbursement and VHL/local-procedure suitability must be checked locally. Confidence/conflicts: high for EMA authorisation and conditional-approval wording; no conflict identified.
  • lenvatinib (Kisplyx) with pembrolizumab (Keytruda)[6]Approvedclear-cell histology or clear-cell component; non-clear-cell histology specifically excluded from reimbursement support in the fetched source; first-line advanced RCC with clear-cell histology or a clear-cell component. · HAS says available data do not define the role of lenvatinib/pembrolizumab versus other immunotherapy-containing combinations. The economic section notes that the efficiency of the product was not demonstrated for the population for which ASMR III versus sunitinib was claimed. Confidence/conflicts: High for HAS first-line reimbursement scope and non-clear-cell exclusion. No conflict identified.
  • lenvatinib (Kisplyx) with pembrolizumab; lenvatinib (Kisplyx) with everolimus[7]EMA authorisedfirst-line advanced RCC with pembrolizumab; following one prior VEGF-targeted therapy with everolimus. · Central authorisation does not establish reimbursement. Prior VEGF-targeted therapy is required for the everolimus combination indication. Confidence/conflicts: high for EMA product-detail indication wording; no conflict identified.
  • nivolumab (Opdivo) monotherapy; nivolumab (Opdivo) with ipilimumab; nivolumab (Opdivo) with cabozantinib[8]EMA authorisedIMDC/intermediate-poor risk is specified for ipilimumab combination; no biomarker restriction stated; post-prior-therapy monotherapy; first-line intermediate/poor-risk advanced RCC for nivolumab+ipilimumab; first-line advanced RCC for nivolumab+cabozantinib. · EMA authorisation does not establish local reimbursement or clinical fit. Risk group, histology, autoimmune conditions, organ function, and prior therapy should be reviewed. Confidence/conflicts: high for EMA indication wording; no conflict identified.
  • nivolumab (Opdivo) with cabozantinib (Cabometyx)[9]ApprovedIMDC risk profile used for G-BA assessment groups; no molecular biomarker stated; first-line treatment of previously untreated advanced RCC. · This is an added-benefit/reimbursement assessment, not a complete EMA product label. "Additional benefit not proven" is not a clinical recommendation against use and does not mean the regimen is unavailable; local prescribing and reimbursement require German-context review. Confidence/conflicts: High for the G-BA resolution's assessed setting and added-benefit conclusion; no conflict identified in fetched sources.
  • nivolumab (Opdivo) with cabozantinib (Cabometyx)[10]Approvedclear-cell histology or clear-cell component; non-clear-cell histology specifically excluded from reimbursement support in the fetched source; first-line advanced RCC with clear-cell histology or a clear-cell component. · HAS states the regimen is a new treatment option, but available data do not define its role versus pembrolizumab/axitinib or nivolumab/ipilimumab in relevant comparator settings. Reimbursement language applies to the stated French population and does not establish individual eligibility. Confidence/conflicts: High for HAS reimbursement opinion and clear-cell/non-clear-cell distinction. No conflict identified.
  • pembrolizumab (Keytruda)[11]EMA authorisedadjuvant treatment after nephrectomy or after nephrectomy plus resection of metastatic lesions. · EMA indication references selection criteria and does not imply all post-nephrectomy patients are eligible. National reimbursement may vary. Confidence/conflicts: high for EMA indication wording; no conflict identified.
  • pembrolizumab (Keytruda)[12]Approvedno molecular biomarker stated; adjuvant treatment after nephrectomy or after nephrectomy plus resection of metastatic lesions. · G-BA's English document is a courtesy translation and only the German version is legally binding. The source reports benefit-assessment findings and estimated German SHI target-population context, not individualized eligibility, duration, or payer authorization. Confidence/conflicts: High for G-BA assessed adjuvant RCC indication and added-benefit conclusion; no conflict identified in fetched sources.
  • pembrolizumab (Keytruda)[13]Approvedclear-cell histology; no molecular biomarker stated; adjuvant treatment after nephrectomy or after nephrectomy plus resection of metastatic lesions in clear-cell RCC at increased recurrence risk. · The source is a French-language HAS PDF; original-source clinical/regulatory interpretation needs human review before patient-facing reuse. The opinion concerns French reimbursement/listing context and does not establish individual eligibility, duration, or centre-level access. Confidence/conflicts: Medium-high for the original HAS PDF wording; marked for human review because the source is French. No conflict identified. Primary source not in English. English summary pending human review — confirm exact wording with your care team.
  • pembrolizumab (Keytruda) with axitinib[14]ApprovedIMDC risk profile used for G-BA assessment groups; no molecular biomarker stated; first-line treatment of advanced RCC in adults. · G-BA benefit assessments are German reimbursement/added-benefit decisions and the English PDF is a courtesy translation; only the German version is legally binding. This cell does not establish individual statutory-insurance authorization, centre availability, or Germany-specific sequencing beyond the assessed indication. Confidence/conflicts: High for G-BA assessed indication and additional-benefit finding; no conflict identified in fetched sources.
  • pembrolizumab (Keytruda) with axitinib (Inlyta)[15]Approvedclear-cell histology or clear-cell component; IMDC prognosis discussed by HAS; first-line advanced RCC, all prognoses combined, for clear-cell RCC or RCC with a clear-cell component. · HAS reimbursement opinions do not replace EMA marketing authorization, local hospital formulary, or patient-level reimbursement confirmation. HAS notes uncertainty about the role of the combination versus nivolumab/ipilimumab in intermediate or unfavourable prognosis subgroups and recommends multidisciplinary decision-making. Confidence/conflicts: High for HAS reimbursement opinion and first-line clear-cell scope. No conflict identified.
  • pembrolizumab (Keytruda) with axitinib; pembrolizumab (Keytruda) with lenvatinib (Kisplyx)[11]EMA authorisedfirst-line advanced renal cell carcinoma. · EMA central authorisation does not determine member-state reimbursement, local formulary access, or individual suitability for VEGF-TKI plus immunotherapy treatment. Confidence/conflicts: high for EMA indication wording; no conflict identified. Member-state access remains separate.
  • pembrolizumab (Keytruda) with lenvatinib (Lenvima)[16]ApprovedIMDC risk profile used for G-BA assessment groups; no molecular biomarker stated; first-line treatment of previously untreated advanced RCC. · This is a German added-benefit decision, not a standalone EMA authorization record or a patient-level access decision. "Additional benefit not proven" reflects the G-BA comparator assessment and should not be interpreted as lack of regulatory approval. Confidence/conflicts: High for G-BA assessed first-line RCC setting and added-benefit conclusion; no conflict identified in fetched sources.

United Kingdom

  • belzutifan (Welireg)[17]Approved (restricted indication)VHL disease; VHL-associated tumours when localised procedures are unsuitable or undesirable. · NICE says belzutifan is not recommended for routine use yet because more evidence is needed; availability is through managed access and commercial arrangements. Confidence/conflicts: high for NICE managed-access wording; no conflict identified.
  • chemotherapy[18]Standard option (per NHS)certain types of kidney cancer; NHS does not specify stage or regimen. · This is a broad category statement. Clear-cell RCC is generally managed with other systemic approaches, but the NHS page does not define the exact subtypes or regimens. Confidence/conflicts: medium-high for broad NHS category listing; no conflict identified.
  • lenvatinib (Kisplyx) with pembrolizumab (Keytruda)[19]NICE recommendedintermediate or poor risk by International Metastatic Renal Cell Carcinoma Database Consortium criteria; untreated advanced RCC. · NICE does not recommend this for favourable-risk cancer in TA858. NICE guidance is England-focused and subject to commercial arrangements. Confidence/conflicts: high for NICE recommendation wording; no conflict identified.
  • nephrectomy and partial nephrectomy; arterial embolisation if surgery is not suitable[18]Standard option (per NHS)early kidney cancer that has not spread; symptom-control context for arterial embolism if surgery is unsuitable. · NHS guidance is broad and does not specify tumor size, stage, nephron-sparing feasibility, or individual surgical risk. Confidence/conflicts: high for broad NHS treatment-category listing; no conflict identified.
  • pembrolizumab (Keytruda)[20]Approvedadjuvant after nephrectomy, with or without metastatic lesion resection. · Increased recurrence risk and marketing authorisation criteria must be assessed; NICE guidance is England-focused and subject to a commercial arrangement. Confidence/conflicts: high for NICE recommendation wording; no conflict identified.
  • radiotherapy[18]Standard option (per NHS)symptom control when cancer cannot be removed by surgery or has spread. · NHS guidance frames radiotherapy mainly as symptom control and does not specify dose, target site, or SBRT/SABR use. Confidence/conflicts: high for broad NHS treatment-category listing; no conflict identified.

Japan

  • belzutifan (Welireg)[21]PMDA-approved (Japan)progressed after cancer chemotherapy; VHL disease-associated tumors. · The PMDA list does not provide full Japanese label wording, exact prior-therapy sequence, or reimbursement conditions. Current electronic package insert review is needed before patient-facing reuse. Confidence/conflicts: medium-high for PMDA approval-list wording; no conflict identified.
  • lenvatinib (Lenvima) with pembrolizumab (Keytruda)[21]PMDA-approved (Japan)unresectable or metastatic renal cell carcinoma; treatment line not specified in the PMDA list entry. · The extracted PMDA list entries do not spell out the combination wording or treatment line. Current Japanese label review is needed to confirm exact regimen and access. Confidence/conflicts: medium for PMDA approval-list wording because combination/line details require current Japanese label verification; no conflict identified. Availability/reimbursement outside the approving regulator not established.
  • nivolumab (Opdivo) with cabozantinib (Cabometyx)[21]PMDA-approved (Japan)unresectable or metastatic renal cell carcinoma; treatment line not specified in the PMDA list entry. · The PMDA list does not fully specify the combination indication, first-line status, risk group, or reimbursement criteria. Current Japanese label review is needed. Confidence/conflicts: medium for PMDA approval-list wording because full combination detail requires label verification; no conflict identified.
  • nivolumab (Opdivo) with ipilimumab (Yervoy)[21]PMDA-approved (Japan)unresectable or metastatic renal cell carcinoma; treatment line/risk group not specified in the PMDA list entry. · The PMDA list does not specify IMDC risk group, treatment line, or reimbursement details. Current Japanese package insert should be checked before patient-facing reuse. Confidence/conflicts: medium-high for PMDA approval-list wording; no conflict identified.
  • pembrolizumab (Keytruda)[21]PMDA-approved (Japan)postoperative adjuvant treatment. · The PMDA list does not specify recurrence-risk criteria, histology, duration, or reimbursement rules. Current Japanese label review is needed. Confidence/conflicts: medium-high for PMDA approval-list wording; no conflict identified.

Australia

  • axitinib (Inlyta)[22]Standard option (per eviQ / Cancer Institute NSW)clear-cell histology; advanced or metastatic clear-cell RCC after failure of one prior systemic therapy. · eviQ is an Australian cancer-protocol resource rather than the PBS schedule or TGA product-information page. The protocol cost is a guide, not the patient cost, and local PBS authority criteria and institutional policy must be checked. Confidence/conflicts: High for eviQ protocol indication and PBS-authority notation; exact current PBS restriction should be checked in PBS schedule. No conflict identified.
  • nivolumab (Opdivo) with ipilimumab (Yervoy)[23]TGA-registered (Australia)IMDC intermediate-to-poor risk criteria; clear-cell variant histology; first-line Stage IV clear-cell variant RCC for IMDC intermediate-to-poor risk. · The DUSC document is a PBS utilisation/review document and includes PBS listing details as at 2021; current PBS item restrictions should be checked before use. It does not establish patient-specific eligibility or private/public hospital access logistics. Confidence/conflicts: High for PBS listing history and TGA indication text in the fetched DUSC source; current item-level criteria should be rechecked. No conflict identified. Availability/reimbursement outside the approving regulator not established.
  • pembrolizumab (Keytruda)[24]Approvedadjuvant/post-surgery RCC at intermediate-high or high risk of recurrence, per the Department of Health release. · Medicine Status directs readers to the PBAC public summary document and PBS schedule for full restriction details. The media release is public-facing and does not substitute for exact PBS authority criteria, TGA product information, or specialist assessment. Confidence/conflicts: High for PBS listing date/status and government announcement scope; exact PBS restriction details remain a gap. No conflict identified. Availability/reimbursement outside the approving regulator not established.
  • pembrolizumab (Keytruda) with lenvatinib (Lenvima)[25]ApprovedRCC PBS listing context; search result and PBAC document title identify pembrolizumab plus lenvatinib for RCC, but the fetched Medicine Status page itself defers detailed listing restrictions to the public summary document and PBS schedule. · The fetched source verifies PBS process status and listing date but does not display the full clinical restriction text. Full PBS schedule/PSD review is required before patient-facing integration of exact line, histology, and combination criteria. Confidence/conflicts: Medium-high for PBS listing status and date; medium for exact combination restriction because full PSD/schedule text was not fetched in this cycle. No conflict identified. Availability/reimbursement outside the approving regulator not established.

Russia

  • Cytoreductive nephrectomy, metastasectomy, stereotactic radiotherapy, and palliative radiotherapy for painful bone metastases or symptomatic CNS metastases[26]Standard option (per Russian Society of Clinical Oncology / RosOncoWeb)IMDC/MSKCC risk factors and histology guide selection; not biomarker-selected; Local-control decisions in metastatic RCC before, after, or alongside systemic therapy. · Selection depends on surgical fitness, risk group, symptom burden, primary-tumor resectability, timing and number of metastases, CNS/bone symptoms, and multidisciplinary review. Confidence/conflicts: High for guideline framework; center capability and access not inferred. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
  • Cytoreductive nephrectomy, metastasectomy, stereotactic radiotherapy, and palliative radiotherapy for painful bone metastases or symptomatic CNS metastases[26]Standard option (per Russian Society of Clinical Oncology / RosOncoWeb)IMDC/MSKCC risk factors and histology guide selection; not biomarker-selected; Local-control decisions in metastatic RCC before, after, or alongside systemic therapy. · Selection depends on surgical fitness, risk group, symptom burden, primary-tumor resectability, timing and number of metastases, CNS/bone symptoms, and multidisciplinary review. Confidence/conflicts: High for guideline framework; center capability and access not inferred. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
  • Cytoreductive nephrectomy, metastasectomy, stereotactic radiotherapy, and palliative radiotherapy for painful bone metastases or symptomatic CNS metastases[26]Standard option (per Russian Society of Clinical Oncology / RosOncoWeb)IMDC/MSKCC risk factors and histology guide selection; not biomarker-selected; Local-control decisions in metastatic RCC before, after, or alongside systemic therapy. · Selection depends on surgical fitness, risk group, symptom burden, primary-tumor resectability, timing and number of metastases, CNS/bone symptoms, and multidisciplinary review. Confidence/conflicts: High for guideline framework; center capability and access not inferred. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
  • Partial nephrectomy / kidney resection, nephrectomy, selected ablation or active surveillance alternative, and adjuvant pembrolizumab (Keytruda-class)[26]Standard option (per Russian Society of Clinical Oncology / RosOncoWeb)Histologic subtype and risk features relevant; not biomarker-selected; Primary treatment for localized/locally advanced RCC; adjuvant immunotherapy after radical surgery in stated risk groups. · Ablation is not part of the standard treatment but may be considered with dynamic observation in very high operative-risk patients with small peripheral tumors. Adjuvant radiation is not recommended after radical surgery in this guideline. Pembrolizumab access/reimbursement was not independently verified. Confidence/conflicts: High for RUSSCO pathway; 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.
  • Partial nephrectomy / kidney resection, nephrectomy, selected ablation or active surveillance alternative, and adjuvant pembrolizumab (Keytruda-class)[26]Standard option (per Russian Society of Clinical Oncology / RosOncoWeb)Histologic subtype and risk features relevant; not biomarker-selected; Primary treatment for localized/locally advanced RCC; adjuvant immunotherapy after radical surgery in stated risk groups. · Ablation is not part of the standard treatment but may be considered with dynamic observation in very high operative-risk patients with small peripheral tumors. Adjuvant radiation is not recommended after radical surgery in this guideline. Pembrolizumab access/reimbursement was not independently verified. Confidence/conflicts: High for RUSSCO pathway; 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.
  • Partial nephrectomy / kidney resection, nephrectomy, selected ablation or active surveillance alternative, and adjuvant pembrolizumab (Keytruda-class)[26]Standard option (per Russian Society of Clinical Oncology / RosOncoWeb)Histologic subtype and risk features relevant; not biomarker-selected; Primary treatment for localized/locally advanced RCC; adjuvant immunotherapy after radical surgery in stated risk groups. · Ablation is not part of the standard treatment but may be considered with dynamic observation in very high operative-risk patients with small peripheral tumors. Adjuvant radiation is not recommended after radical surgery in this guideline. Pembrolizumab access/reimbursement was not independently verified. Confidence/conflicts: High for RUSSCO pathway; 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.
  • Pembrolizumab plus lenvatinib, nivolumab plus cabozantinib, pembrolizumab plus axitinib, avelumab plus axitinib, nivolumab plus ipilimumab, pazopanib, sunitinib, and cabozantinib[26]Standard option (per Russian Society of Clinical Oncology / RosOncoWeb)IMDC favorable vs intermediate/poor risk; sarcomatoid differentiation noted separately in guideline; First-line systemic therapy for disseminated clear-cell RCC. · Treatment choice depends on histology, sarcomatoid component, IMDC risk group, contraindications, prior treatment, tumor burden, symptoms, and access. This batch did not verify Russian regulator or payer status for each named drug. Confidence/conflicts: High for RUSSCO algorithm; access and reimbursement remain source-pending. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
  • Pembrolizumab plus lenvatinib, nivolumab plus cabozantinib, pembrolizumab plus axitinib, avelumab plus axitinib, nivolumab plus ipilimumab, pazopanib, sunitinib, and cabozantinib[26]Standard option (per Russian Society of Clinical Oncology / RosOncoWeb)IMDC favorable vs intermediate/poor risk; sarcomatoid differentiation noted separately in guideline; First-line systemic therapy for disseminated clear-cell RCC. · Treatment choice depends on histology, sarcomatoid component, IMDC risk group, contraindications, prior treatment, tumor burden, symptoms, and access. This batch did not verify Russian regulator or payer status for each named drug. Confidence/conflicts: High for RUSSCO algorithm; access and reimbursement remain source-pending. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.

Thailand

  • Axitinib (Inlyta)[27]ApprovedNot biomarker-selected in source; Advanced RCC after one prior systemic therapy. · Thai-language document needs human review; NDI label text does not establish reimbursement, current sequencing after immunotherapy/TKI combinations, or individual suitability. Confidence/conflicts: Medium-high; Thai NDI source supports the post-prior-systemic-therapy indication, but modern sequencing and payer status are not established. Primary source is in Thai. English summary pending human review — confirm exact wording with your care team.
  • Cabozantinib (Cabometyx) monotherapy or cabozantinib plus nivolumab[28]ApprovedNot biomarker-selected in source; Treatment-naive intermediate/poor-risk advanced RCC, post-VEGF-targeted therapy advanced RCC, and first-line advanced RCC in combination with nivolumab per later document. · NDI documents support label indications but not reimbursement, nivolumab Thai label cross-check, IMDC risk assignment, or sequencing after immunotherapy combinations. Confidence/conflicts: High for Cabometyx RCC indication text; combination use should be cross-checked against current nivolumab Thai product document before patient-facing display.
  • Cabozantinib (Cabometyx) monotherapy or cabozantinib plus nivolumab[28]ApprovedNot biomarker-selected in source; Treatment-naive intermediate/poor-risk advanced RCC, post-VEGF-targeted therapy advanced RCC, and first-line advanced RCC in combination with nivolumab per later document. · NDI documents support label indications but not reimbursement, nivolumab Thai label cross-check, IMDC risk assignment, or sequencing after immunotherapy combinations. Confidence/conflicts: High for Cabometyx RCC indication text; combination use should be cross-checked against current nivolumab Thai product document before patient-facing display.
  • Pembrolizumab (Keytruda) monotherapy[29]ApprovedNot biomarker-selected in source; Adjuvant treatment after nephrectomy, or after nephrectomy plus resection of metastatic lesions, in intermediate-high or high recurrence-risk RCC. · NDI indication text does not establish individual recurrence-risk classification, pathology criteria, timing, reimbursement, or availability. Confidence/conflicts: High for Thai NDI indication text; access not established.
  • Pembrolizumab (Keytruda) plus axitinib (Inlyta)[29]ApprovedNot biomarker-selected in source; First-line treatment of advanced RCC. · Thai NDI supports indication text but not reimbursement, center formulary availability, sequencing after prior therapy, or individual suitability. Axitinib's Thai NDI document also supports axitinib as an RCC drug but separately lists post-prior-systemic-therapy monotherapy wording, so the Keytruda combination label is the primary support for the first-line combination. Confidence/conflicts: High for Keytruda plus axitinib first-line RCC indication text; Thai-language axitinib details need human review. Primary source is in Thai. English summary pending human review — confirm exact wording with your care team.
  • Pembrolizumab (Keytruda) plus axitinib (Inlyta)[29]ApprovedNot biomarker-selected in source; First-line treatment of advanced RCC. · Thai NDI supports indication text but not reimbursement, center formulary availability, sequencing after prior therapy, or individual suitability. Axitinib's Thai NDI document also supports axitinib as an RCC drug but separately lists post-prior-systemic-therapy monotherapy wording, so the Keytruda combination label is the primary support for the first-line combination. Confidence/conflicts: High for Keytruda plus axitinib first-line RCC indication text; Thai-language axitinib details need human review. Primary source is in Thai. English summary pending human review — confirm exact wording with your care team.
  • Pembrolizumab (Keytruda) plus lenvatinib (Lenvima-class)[29]ApprovedNot biomarker-selected in source; First-line treatment of advanced RCC. · NDI Keytruda document supports the pembrolizumab component and combination indication; this batch did not verify a separate current Thai lenvatinib product PDF for RCC, reimbursement, or formulary access. Confidence/conflicts: Medium-high; Keytruda source supports the combination indication, but separate Thai lenvatinib label and payer status remain unverified.
  • Pembrolizumab (Keytruda) plus lenvatinib (Lenvima-class)[29]ApprovedNot biomarker-selected in source; First-line treatment of advanced RCC. · NDI Keytruda document supports the pembrolizumab component and combination indication; this batch did not verify a separate current Thai lenvatinib product PDF for RCC, reimbursement, or formulary access. Confidence/conflicts: Medium-high; Keytruda source supports the combination indication, but separate Thai lenvatinib label and payer status remain unverified.
  • cabozantinib (Cabometyx) monotherapy; cabozantinib (Cabometyx) with nivolumab[28]Approvednot required by the fetched Cabometyx label indication; first-line intermediate/poor-risk advanced RCC monotherapy; post-VEGF-targeted therapy monotherapy; first-line advanced RCC with nivolumab. · The fetched Cabometyx label verifies cabozantinib indication and registration numbers but does not itself verify the Thai nivolumab partner label, payer access, or current local sequencing against pembrolizumab-based combinations. Confidence/conflicts: High for Thai NDI Cabometyx monotherapy and cabozantinib-plus-nivolumab indication text; medium for the full combination because a Thai nivolumab partner label was not fetched this cycle. No direct conflict identified. Availability/reimbursement outside the approving regulator not established.
  • pembrolizumab (Keytruda)[29]Approvednot required by the fetched Keytruda label indication; adjuvant treatment after nephrectomy, with or without resection of metastatic lesions, for intermediate-high or high recurrence risk. · The label does not define the risk categories in the excerpted indication. Reimbursement, duration, surveillance schedule, and multidisciplinary fit after surgery remain unresolved. Confidence/conflicts: High for Thai NDI adjuvant RCC indication text; reimbursement and detailed risk criteria remain gaps. No conflict identified.
  • pembrolizumab (Keytruda) with axitinib; pembrolizumab (Keytruda) with lenvatinib[29]Approvednot required by the fetched Keytruda label indications; first-line treatment for advanced RCC. · The fetched source verifies the Keytruda component's Thailand label wording but does not establish partner-drug reimbursement, Thai payer access, IMDC risk subgrouping, or hospital formulary availability. Partner prescribing information remains useful for complete combination review. Confidence/conflicts: High for Thai NDI Keytruda RCC combination indication text; partner-drug labels and reimbursement remain gaps. No conflict identified.

출처

  1. U.S. Food and Drug Administration (FDA) — regulator approval notice · regulator approval notice
  2. National Cancer Institute (NCI) — national cancer agency evidence summary · national cancer agency evidence summary
  3. U.S. Food and Drug Administration (FDA) — regulator approval notice / FDA D.I.S.C.O. Burst · regulator approval notice / FDA D.I.S.C.O. Burst
  4. U.S. Food and Drug Administration (FDA) — regulator approval notice · regulator approval notice
  5. European Medicines Agency (EMA) — regulator EPAR · regulator EPAR
  6. Haute Autorite de Sante (HAS) — Transparency Committee drug opinion / reimbursement summary · Transparency Committee drug opinion / reimbursement summary
  7. European Medicines Agency (EMA) — regulator EPAR · regulator EPAR
  8. European Medicines Agency (EMA) — regulator EPAR · regulator EPAR
  9. Gemeinsamer Bundesausschuss (G-BA) — benefit-assessment resolution / HTA reimbursement decision · benefit-assessment resolution / HTA reimbursement decision
  10. Haute Autorite de Sante (HAS) — Transparency Committee drug opinion / reimbursement summary · Transparency Committee drug opinion / reimbursement summary
  11. European Medicines Agency (EMA) — regulator EPAR · regulator EPAR
  12. Gemeinsamer Bundesausschuss (G-BA) — benefit-assessment resolution / HTA reimbursement decision · benefit-assessment resolution / HTA reimbursement decision
  13. Haute Autorite de Sante (HAS) — Transparency Committee drug opinion PDF / reimbursement reassessment · Transparency Committee drug opinion PDF / reimbursement reassessment
  14. Gemeinsamer Bundesausschuss (G-BA) — benefit-assessment justification / HTA reimbursement decision · benefit-assessment justification / HTA reimbursement decision
  15. Haute Autorite de Sante (HAS) — Transparency Committee drug opinion / reimbursement summary · Transparency Committee drug opinion / reimbursement summary
  16. Gemeinsamer Bundesausschuss (G-BA) — benefit-assessment resolution / HTA reimbursement decision · benefit-assessment resolution / HTA reimbursement decision
  17. National Institute for Health and Care Excellence (NICE) — technology appraisal guidance / managed access recommendation · technology appraisal guidance / managed access recommendation
  18. NHS — national health service patient treatment guidance · national health service patient treatment guidance
  19. National Institute for Health and Care Excellence (NICE) — technology appraisal guidance · technology appraisal guidance
  20. National Institute for Health and Care Excellence (NICE) — technology appraisal guidance · technology appraisal guidance
  21. Pharmaceuticals and Medical Devices Agency (PMDA) — regulator approved-drug list · regulator approved-drug list
  22. eviQ / Cancer Institute NSW — endorsed oncology treatment protocol · endorsed oncology treatment protocol
  23. Australian Pharmaceutical Benefits Scheme (PBS) / Drug Utilisation Sub-Committee (DUSC) — public release utilisation review / PBS listing context · public release utilisation review / PBS listing context
  24. Australian Government Department of Health, Disability and Ageing — government media release / PBS listing announcement · government media release / PBS listing announcement
  25. Australian Pharmaceutical Benefits Scheme (PBS) Medicine Status Website — medicine status / PBAC-to-PBS listing tracker · medicine status / PBAC-to-PBS listing tracker
  26. Russian Society of Clinical Oncology (RUSSCO) / RosOncoWeb — professional society clinical recommendations PDF · professional society clinical recommendations PDF
  27. Thai National Drug Information / Thai FDA-MOPH — prescribing information PDF / regulator drug-information repository · prescribing information PDF / regulator drug-information repository
  28. Thai National Drug Information / Thai FDA-MOPH — prescribing information PDF / regulator drug-information repository · prescribing information PDF / regulator drug-information repository
  29. Thai National Drug Information / Thai FDA-MOPH — prescribing information PDF / regulator drug-information repository · prescribing information PDF / regulator drug-information repository

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