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Urothelial / bladder 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

avelumab (Bavencio)[1]FDA-approvedno biomarker requirement stated in the FDA indication; first-line maintenance after no progression on platinum-containing chemotherapy; also previously treated post-platinum locally advanced/metastatic UC per label. · The FDA label is broad urothelial carcinoma and does not separately name upper-tract primaries in the fetched indication text. Maintenance use requires the disease has not progressed after first-line platinum-containing chemotherapy. Confidence/conflicts: High for U.S. FDA maintenance indication; no conflict identified. UTUC-specific primary-site evidence remains a caveat.
cisplatin-based multiagent chemotherapy; platinum-based chemotherapy with gemcitabine/cisplatin or gemcitabine/carboplatin in advanced disease contexts [2]Standard option (per NCI PDQ)neoadjuvant before radical cystectomy in stage II/III; stage IV locally advanced/metastatic systemic therapy contexts. · Cisplatin eligibility, renal function, neuropathy/hearing status, performance status, and prior therapy determine regimen choice. This is not a dosing or regimen recommendation. Confidence/conflicts: high for NCI/FDA context; no conflict identified.
combination chemotherapy frameworks extrapolated from metastatic bladder cancer, including M-VAC; additional active agents listed by PDQ include paclitaxel, ifosfamide, gallium nitrate, gemcitabine, and pemetrexed [3]NCI PDQ: standard optionmetastatic or recurrent upper tract urothelial cancer. · The source does not frame these as UTUC-specific approvals and emphasizes poor prognosis plus individualization based on recurrence site, prior therapy, and patient factors. Some listed agents had limited activity after prior cisplatin. Confidence/conflicts: High for NCI PDQ metastatic/recurrent treatment framing; no conflict identified.
enfortumab vedotin-ejfv (Padcev) with pembrolizumab (Keytruda)[2]FDA-approvedno biomarker restriction in FDA approval notice; trial stratified by PD-L1 expression and cisplatin eligibility; locally advanced or metastatic urothelial cancer; no prior systemic therapy for advanced disease in the pivotal trial described by FDA. · FDA approval does not imply individual eligibility. Neuropathy, rash, glucose, eye, immune-related, renal, and other safety issues require label review and oncology judgment. Confidence/conflicts: high for FDA approval notice; no conflict identified. Full FDA approval since 15 Dec 2023 (converted from the April 2023 accelerated approval, which had been limited to cisplatin-ineligible patients) for first-line locally advanced/metastatic urothelial cancer; confirmatory Phase 3 EV-302/KEYNOTE-A39 met OS (31.5 vs 16.1 mo) and PFS endpoints. This is the current first-line standard of care. The 'accelerated approval' wording is correct only as superseded historical context.
enfortumab vedotin-ejfv (Padcev) with pembrolizumab (Keytruda)[4]FDA-approvednot required by the FDA Padcev indication; Nectin-4 is the drug target but the label does not require biomarker testing in the recorded indication; locally advanced or metastatic urothelial cancer; EV-302 enrolled patients with no prior systemic therapy for advanced disease. · The official label is broad urothelial cancer, not a UTUC-only indication. The FDA label includes boxed-warning and precaution language for severe skin reactions, hyperglycemia, pneumonitis/ILD, peripheral neuropathy, ocular disorders, infusion-site extravasation, and embryo-fetal toxicity. Confidence/conflicts: High for U.S. approval and urinary-tract/renal-pelvis/ureter wording from the FDA label. No conflict identified. Full FDA approval since 15 Dec 2023 (converted from the April 2023 accelerated approval, which had been limited to cisplatin-ineligible patients) for first-line locally advanced/metastatic urothelial cancer; confirmatory Phase 3 EV-302/KEYNOTE-A39 met OS (31.5 vs 16.1 mo) and PFS endpoints. This is the current first-line standard of care. The 'accelerated approval' wording is correct only as superseded historical context.
erdafitinib (Balversa)[5]FDA-approvedsusceptible FGFR3 genetic alterations as determined by an FDA-approved companion diagnostic; progression on or after at least one prior line of systemic therapy. · FDA states erdafitinib is not recommended for patients eligible for and not yet treated with prior PD-1 or PD-L1 inhibitor therapy. FGFR3 testing with an FDA-approved companion diagnostic is required. Confidence/conflicts: high for FDA approval/label wording; no conflict identified.
erdafitinib (Balversa)[6]FDA-approvedsusceptible FGFR3 genetic alterations detected by an FDA-approved companion diagnostic; locally advanced or metastatic urothelial carcinoma after at least one prior systemic therapy. · The FDA label says Balversa is not recommended for patients who are eligible for and have not received prior PD-1 or PD-L1 inhibitor therapy. The label is broad urothelial carcinoma and does not separately name upper-tract primaries in the fetched indication text. Confidence/conflicts: High for U.S. FDA approval and FGFR3 companion-diagnostic requirement; no conflict identified. UTUC-specific evidence and payer access remain separate questions.
external-beam radiation therapy (EBRT) with or without concomitant chemotherapy; bladder-preservation chemoradiation approaches [7]Standard option (per NCI PDQ)stage II/III muscle-invasive disease and selected stage IV T4b N0 M0 contexts. · Suitability for bladder-sparing chemoradiation depends on tumor features, hydronephrosis, completeness of TUR, bladder function, renal function, and multidisciplinary evaluation. Confidence/conflicts: high for NCI option listing; no conflict identified.
nephroureterectomy with bladder cuff excision [3]NCI PDQ: standard optionlocalized upper tract urothelial cancer. · The PDQ source is a national cancer treatment summary, not a patient-specific surgical recommendation. Surgical suitability depends on tumor extent, renal function, anatomy, and whether kidney-sparing management is feasible. Confidence/conflicts: High for U.S. NCI PDQ treatment-option listing; no conflict identified.
nivolumab (Opdivo)[8]FDA-approvednot required by the U.S. FDA indication; PD-L1 status was a stratification/subgroup factor in CheckMate-274; adjuvant treatment after radical resection of urothelial carcinoma at high risk of recurrence; CheckMate-274 included radical resection of upper urinary tract tumors. · The FDA label is for urothelial carcinoma broadly. It notes an exploratory upper-tract subgroup in which disease-free survival improvement was not observed, so this cell should be surfaced as an FDA-approved option to discuss, not as a UTUC-specific efficacy claim. Confidence/conflicts: High for U.S. FDA-approved adjuvant urothelial-carcinoma indication and explicit inclusion of renal pelvis/ureter tumors in CheckMate-274. Important caveat: the same label reports no observed DFS improvement in the exploratory upper-tract subgroup.
transurethral resection (TUR) with fulguration, segmental cystectomy in selected patients, radical cystectomy with pelvic lymph-node dissection, urinary diversion/cystectomy for palliation [7]Standard option (per NCI PDQ)stage 0/I nonmuscle-invasive contexts; stage II/III muscle-invasive contexts; palliative stage IV contexts. · NCI PDQ is an evidence summary, not a personalized surgical plan. Tumor stage, grade, carcinoma in situ, recurrence risk, surgical fitness, renal function, and patient goals affect whether surgery is discussed. Confidence/conflicts: high for NCI stage-based option listing; no conflict identified.

European Union

avelumab (Bavencio)[9]EMA authorisedfirst-line maintenance after platinum-based chemotherapy when disease has not progressed. · EMA authorisation does not determine member-state reimbursement, infusion availability, or whether maintenance therapy is clinically suitable. Confidence/conflicts: high for EMA product-detail indication wording; no conflict identified.
enfortumab vedotin (Padcev) monotherapy [10]EMA authorisednot restricted beyond prior therapy context in the EMA indication; after prior platinum-containing chemotherapy and prior PD-1 or PD-L1 inhibitor therapy. · EMA authorisation does not determine whether a specific EU country reimburses Padcev monotherapy or whether a patient meets clinical suitability criteria. Confidence/conflicts: high for EMA indication wording; no conflict identified.
enfortumab vedotin (Padcev) with pembrolizumab [10]EMA authorisedno biomarker restriction stated for the combination indication; EMA product page states patients are eligible for platinum-containing chemotherapy; first-line unresectable or metastatic urothelial cancer. · EMA central authorisation does not establish reimbursement or routine access in each member state. The product page frames use as prescription-only and supervised by a doctor experienced in cancer medicines. Confidence/conflicts: high for EMA authorisation and indication wording; no conflict identified. Member-state access remains separate.
enfortumab vedotin (Padcev) with pembrolizumab [10]EMA authorisedno biomarker requirement stated in the fetched EMA therapeutic indication; first-line treatment of unresectable or metastatic urothelial cancer in adults eligible for platinum-containing chemotherapy. · EMA describes urothelial cancer as cancer of the bladder and urinary tract, but the fetched EPAR text does not separately list renal pelvis or ureter in the therapeutic-indication line. Member-state reimbursement, including Germany and France, remains separate from EMA authorisation. Confidence/conflicts: High for EU first-line unresectable/metastatic urothelial-cancer authorisation; medium-high for direct upper-tract mapping because EMA wording is broad urinary-tract cancer rather than site-specific in the indication line. No conflict identified.
erdafitinib (Balversa)[11]EMA authorisedsusceptible FGFR3 genetic alterations; after at least one prior line containing a PD-1 or PD-L1 inhibitor in unresectable or metastatic treatment. · FGFR3 alteration status is required by the EMA indication. Central authorisation does not confirm local reimbursement, testing access, or clinical suitability. Confidence/conflicts: high for EMA authorisation and indication wording; no conflict identified.
nivolumab (Opdivo)[12]EMA authorisedtumour cell PD-L1 expression >=1% per EMA indication; adjuvant treatment after radical resection of high-risk muscle-invasive urothelial carcinoma with PD-L1 tumour-cell expression >=1%. · The fetched EMA indication is for muscle-invasive urothelial carcinoma and does not, in the fetched EPAR page text, separately spell out renal pelvis/ureter. Use for upper-tract disease should be discussed against the full EU SmPC, tumor site, PD-L1 testing, and local reimbursement in the treating member state. Confidence/conflicts: Medium-high for EU adjuvant MIUC approval from EMA; site-specific UTUC applicability needs confirmation from the full SmPC and local oncology team. No direct source conflict identified.

United Kingdom

avelumab (Bavencio)[13]NICE recommendedmaintenance after platinum-based chemotherapy when disease has not progressed. · NICE specifies stopping at 5 years of uninterrupted treatment or earlier if disease progresses, and requires the company commercial arrangement. It does not override individual clinical judgment. Confidence/conflicts: high for NICE recommendation wording; no conflict identified.
bladder cancer surgery, including surgery for primary disease and selected recurrent or metastatic contexts [14]Standard option (per NHS)main treatment; recurrent or spread disease contexts are noted by NHS. · NHS guidance is broad and does not specify an individual operation, surgical fitness, stage, or bladder-preservation suitability. Confidence/conflicts: high for broad NHS treatment-category listing; no conflict identified.
chemotherapy, including intravesical or intravenous chemotherapy and chemoradiotherapy contexts [14]Standard option (per NHS)before surgery/radiotherapy, with radiotherapy, after surgery, or for spread disease. · NHS guidance does not specify regimen selection, eligibility, dosing, renal-function requirements, or whether cisplatin, carboplatin, intravesical agents, or other drugs apply. Confidence/conflicts: high for broad NHS treatment-category listing; no conflict identified.
enfortumab vedotin (Padcev) with pembrolizumab (Keytruda)[15]Approvedno biomarker restriction stated in NICE recommendation; platinum-based chemotherapy must be suitable; untreated unresectable or metastatic disease. · NICE guidance is England-focused and includes commercial arrangement and implementation conditions; devolved-nation pathways may differ. Confidence/conflicts: high for NICE recommendation wording; no conflict identified. Scotland/Wales/Northern Ireland access should be checked separately.
enfortumab vedotin (Padcev) with pembrolizumab (Keytruda)[15]Approvedno biomarker requirement stated in the fetched NICE recommendation; untreated unresectable or metastatic urothelial cancer in adults when platinum-based chemotherapy is suitable. · NICE TA1097 is a reimbursement/use recommendation rather than a UTUC-specific clinical guideline. It does not separately list upper-tract primary sites in the fetched recommendation text, so site-specific applicability and treatment sequencing should be checked by the multidisciplinary team. Confidence/conflicts: High for NICE England/Wales recommendation in the stated unresectable/metastatic urothelial-cancer population; medium for UTUC-specific mapping because the fetched NICE text is broad urothelial cancer. No conflict identified.
erdafitinib (Balversa)[16]Approvedsusceptible FGFR3 genetic alterations; after at least one line of unresectable/metastatic treatment including a PD-1 or PD-L1 inhibitor. · NICE requires susceptible FGFR3 alterations and the commercial arrangement. Testing access, local pathways, and clinical suitability remain separate. Confidence/conflicts: high for NICE recommendation wording; no conflict identified.
nivolumab (Opdivo)[17]NICE recommendedPD-L1 expression at 1% or more per NICE recommendation and UK marketing-authorisation indication; adjuvant treatment after radical resection when high recurrence risk, PD-L1 >=1%, and platinum-based adjuvant chemotherapy is unsuitable. · NICE guidance is a reimbursement/use recommendation, not an individualized eligibility decision. The fetched page is not UTUC-specific, so upper-tract applicability should be checked against the marketing authorisation and local multidisciplinary team interpretation. Confidence/conflicts: High for NICE England/Wales recommendation conditions; medium for direct upper-tract-specific mapping because the NICE page uses invasive/muscle-invasive urothelial cancer wording rather than a UTUC-specific heading. No source conflict identified.
radiotherapy, with or without chemotherapy [14]Standard option (per NHS)alternative to surgery; spread disease; chemoradiotherapy contexts. · NHS guidance does not define which stage or tumor features make radiotherapy appropriate, and does not specify dose, field, or concurrent chemotherapy regimen. Confidence/conflicts: high for broad NHS treatment-category listing; no conflict identified.

Japan

avelumab (Bavencio)[18]PMDA-approved (Japan)maintenance therapy after chemotherapy. · The PMDA list does not specify progression-free status, chemotherapy regimen, duration, or reimbursement criteria. Current Japanese label review is needed before patient-facing reuse. Confidence/conflicts: medium-high for PMDA list entry; no conflict identified.
cisplatin (Randa)[18]PMDA-approved (Japan)urothelial carcinoma; the PMDA list entry does not specify disease stage or line of therapy. · The PMDA list does not define cisplatin eligibility, combination regimen, renal-function requirements, or reimbursement conditions. Confidence/conflicts: medium-high for PMDA approval-list entry; no conflict identified.
enfortumab vedotin (Padcev) monotherapy [18]PMDA-approved (Japan)progressed after cancer chemotherapy. · The PMDA list does not specify all prior-treatment requirements, contraindications, or current reimbursement rules. Current Japanese package insert should be checked before patient-facing reuse. Confidence/conflicts: medium-high for PMDA list entry; no conflict identified.
enfortumab vedotin (Padcev) plus pembrolizumab (Keytruda)[18]PMDA-approved (Japan)no biomarker requirement stated in the fetched PMDA list entry; unresectable urothelial carcinoma; combination-sequencing and first-line details need the full current Japanese package inserts. · The fetched PMDA list verifies approval changes and indication category but does not provide the full label text, combination administration details, reimbursement, or whether renal-pelvis/ureter primaries are separately named. Use as a Japan unresectable-urothelial-carcinoma option to discuss, not a UTUC-only indication. Confidence/conflicts: Medium-high for Japan PMDA approval changes for Padcev and Keytruda in unresectable urothelial carcinoma; full label and UTUC-specific wording remain gaps. No conflict identified.
enfortumab vedotin (Padcev) with pembrolizumab (Keytruda)[18]PMDA-approved (Japan)no biomarker restriction stated in the PMDA list entry; unresectable urothelial carcinoma; the PMDA list entry does not state the treatment line. · The PMDA approved-drug list is a regulator summary and does not provide full Japanese package-insert details, reimbursement conditions, or exact combination-use wording in the extracted English entry. Human review of the current Japanese label is needed before patient-facing reuse. Confidence/conflicts: medium-high for approval-list entries; no conflict identified, but exact label wording requires Japanese package-insert verification.
erdafitinib (Balversa)[18]PMDA-approved (Japan)FGFR3 gene mutation or fusion gene; progressed after cancer chemotherapy. · PMDA list wording identifies FGFR3 mutation or fusion and post-chemotherapy progression, but does not provide testing method, line-of-therapy sequencing, or reimbursement detail. Confidence/conflicts: high for PMDA approval-list wording; no conflict identified.
nivolumab (Opdivo)[19]PMDA-approved (Japan)PD-L1 expression was part of CheckMate-274 endpoints; the fetched Japan approval notice does not frame approval as PD-L1 restricted; postoperative adjuvant therapy for urothelial carcinoma; the company approval notice describes CheckMate-274 as including tumors from the bladder or upper urinary tract, including renal pelvis or ureter, after radical resection and at high recurrence risk. · The PMDA source is a safety/indication summary rather than the full current package insert, and the Ono source is a manufacturer approval announcement. Japanese-language label, reimbursement, and exact current indication wording remain gaps. Confidence/conflicts: Medium-high: PMDA verifies Japanese postoperative adjuvant urothelial-carcinoma indication and Ono verifies the supplemental approval plus upper-urinary-tract inclusion in the supporting trial. Full PMDA package-insert wording remains unresolved; no conflict identified.
nivolumab (Opdivo) plus cisplatin (Randa) with gemcitabine context from prior Japan urothelial-carcinoma approval history [18]PMDA-approved (Japan)no biomarker requirement stated in the fetched PMDA list entries; unresectable urothelial carcinoma; exact combination regimen and first-line wording require the current Japanese labels. · This cell links same-jurisdiction PMDA list entries for Opdivo, cisplatin, and gemcitabine but the fetched list is not a full regimen label. Renal function, cisplatin eligibility, and full package-insert details are unresolved. Confidence/conflicts: Medium for regimen-level interpretation because the PMDA list verifies separate Japanese indication changes but not the complete current regimen label in the fetched text. No direct conflict identified. Availability/reimbursement outside the approving regulator not established.

Russia

Erdafitinib (Balversa-class FGFR inhibitor), enfortumab vedotin (Padcev-class antibody-drug conjugate), trastuzumab deruxtecan (Enhertu-class HER2-directed antibody-drug conjugate), and later-line immunotherapy/chemotherapy options including pembrolizumab, nivolumab, atezolizumab, taxanes, gemcitabine, or vinflunine [20]Standard option (per Russian Society of Clinical Oncology / RosOncoWeb)FGFR3 pathogenic mutations/translocations for erdafitinib; HER2/neu 3+ for trastuzumab deruxtecan context; Second-line after platinum chemotherapy if no prior anti-PD-(L)1 therapy; subsequent therapy after immunotherapy and/or after platinum plus anti-PD-(L)1 exposure. · Requires prior-treatment review and biomarker testing where relevant. This record is guideline-backed; separate Russian marketing authorization, procurement, and reimbursement confirmation remain active gaps. Confidence/conflicts: High for RUSSCO guideline inclusion; regulator and reimbursement status not independently verified. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
Erdafitinib (Balversa-class FGFR inhibitor), enfortumab vedotin (Padcev-class antibody-drug conjugate), trastuzumab deruxtecan (Enhertu-class HER2-directed antibody-drug conjugate), and later-line immunotherapy/chemotherapy options including pembrolizumab, nivolumab, atezolizumab, taxanes, gemcitabine, or vinflunine [20]Standard option (per Russian Society of Clinical Oncology / RosOncoWeb)FGFR3 pathogenic mutations/translocations for erdafitinib; HER2/neu 3+ for trastuzumab deruxtecan context; Second-line after platinum chemotherapy if no prior anti-PD-(L)1 therapy; subsequent therapy after immunotherapy and/or after platinum plus anti-PD-(L)1 exposure. · Requires prior-treatment review and biomarker testing where relevant. This record is guideline-backed; separate Russian marketing authorization, procurement, and reimbursement confirmation remain active gaps. Confidence/conflicts: High for RUSSCO guideline inclusion; regulator and reimbursement status not independently verified. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
Erdafitinib (Balversa-class FGFR inhibitor), enfortumab vedotin (Padcev-class antibody-drug conjugate), trastuzumab deruxtecan (Enhertu-class HER2-directed antibody-drug conjugate), and later-line immunotherapy/chemotherapy options including pembrolizumab, nivolumab, atezolizumab, taxanes, gemcitabine, or vinflunine [20]Standard option (per Russian Society of Clinical Oncology / RosOncoWeb)FGFR3 pathogenic mutations/translocations for erdafitinib; HER2/neu 3+ for trastuzumab deruxtecan context; Second-line after platinum chemotherapy if no prior anti-PD-(L)1 therapy; subsequent therapy after immunotherapy and/or after platinum plus anti-PD-(L)1 exposure. · Requires prior-treatment review and biomarker testing where relevant. This record is guideline-backed; separate Russian marketing authorization, procurement, and reimbursement confirmation remain active gaps. Confidence/conflicts: High for RUSSCO guideline inclusion; regulator and reimbursement status not independently verified. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
Pembrolizumab plus enfortumab vedotin, gemcitabine/cisplatin plus nivolumab, ddMVAC, gemcitabine/cisplatin, gemcitabine/carboplatin, and avelumab maintenance after platinum-based chemotherapy without progression [20]Standard option (per Russian Society of Clinical Oncology / RosOncoWeb)Not biomarker-selected for first-line enfortumab vedotin plus pembrolizumab; platinum eligibility is clinically relevant for chemotherapy/maintenance pathways; Initial systemic therapy for metastatic bladder cancer; maintenance after no progression on platinum-based chemotherapy. · Disseminated disease treatment is described as palliative, aimed at quality and length of life. Choice depends on platinum suitability, performance status, kidney function, neuropathy/hearing/cardiac comorbidity, prior therapy, and access. Confidence/conflicts: High for RUSSCO-listed regimens; no Russian regulator-label or payer status was verified in this batch. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
Pembrolizumab plus enfortumab vedotin, gemcitabine/cisplatin plus nivolumab, ddMVAC, gemcitabine/cisplatin, gemcitabine/carboplatin, and avelumab maintenance after platinum-based chemotherapy without progression [20]Standard option (per Russian Society of Clinical Oncology / RosOncoWeb)Not biomarker-selected for first-line enfortumab vedotin plus pembrolizumab; platinum eligibility is clinically relevant for chemotherapy/maintenance pathways; Initial systemic therapy for metastatic bladder cancer; maintenance after no progression on platinum-based chemotherapy. · Disseminated disease treatment is described as palliative, aimed at quality and length of life. Choice depends on platinum suitability, performance status, kidney function, neuropathy/hearing/cardiac comorbidity, prior therapy, and access. Confidence/conflicts: High for RUSSCO-listed regimens; no Russian regulator-label or payer status was verified in this batch. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
Pembrolizumab plus enfortumab vedotin, gemcitabine/cisplatin plus nivolumab, ddMVAC, gemcitabine/cisplatin, gemcitabine/carboplatin, and avelumab maintenance after platinum-based chemotherapy without progression [20]Standard option (per Russian Society of Clinical Oncology / RosOncoWeb)Not biomarker-selected for first-line enfortumab vedotin plus pembrolizumab; platinum eligibility is clinically relevant for chemotherapy/maintenance pathways; Initial systemic therapy for metastatic bladder cancer; maintenance after no progression on platinum-based chemotherapy. · Disseminated disease treatment is described as palliative, aimed at quality and length of life. Choice depends on platinum suitability, performance status, kidney function, neuropathy/hearing/cardiac comorbidity, prior therapy, and access. Confidence/conflicts: High for RUSSCO-listed regimens; no Russian regulator-label or payer status was verified in this batch. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
Radical cystectomy with neoadjuvant cisplatin-based chemotherapy (ddMVAC or gemcitabine/cisplatin), perioperative durvalumab plus gemcitabine/cisplatin in selected framework, and adjuvant nivolumab or pembrolizumab options in stated postoperative contexts [20]Standard option (per Russian Society of Clinical Oncology / RosOncoWeb)PD-L1 CPS >=1% mentioned for adjuvant nivolumab option after radical cystectomy in source; Curative-intent management for muscle-invasive bladder cancer; neoadjuvant/perioperative and selected adjuvant settings. · Cisplatin eligibility, renal function, performance status, postoperative stage/nodal status, PD-L1 context, timing after cystectomy, and toxicity risks are pathway-defining. This guideline entry does not by itself establish procurement or reimbursement. Confidence/conflicts: High for RUSSCO recommendations; no separate regulator/reimbursement confirmation in this batch. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
Radical cystectomy with neoadjuvant cisplatin-based chemotherapy (ddMVAC or gemcitabine/cisplatin), perioperative durvalumab plus gemcitabine/cisplatin in selected framework, and adjuvant nivolumab or pembrolizumab options in stated postoperative contexts [20]Standard option (per Russian Society of Clinical Oncology / RosOncoWeb)PD-L1 CPS >=1% mentioned for adjuvant nivolumab option after radical cystectomy in source; Curative-intent management for muscle-invasive bladder cancer; neoadjuvant/perioperative and selected adjuvant settings. · Cisplatin eligibility, renal function, performance status, postoperative stage/nodal status, PD-L1 context, timing after cystectomy, and toxicity risks are pathway-defining. This guideline entry does not by itself establish procurement or reimbursement. Confidence/conflicts: High for RUSSCO recommendations; no separate regulator/reimbursement confirmation in this batch. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
Radical cystectomy with neoadjuvant cisplatin-based chemotherapy (ddMVAC or gemcitabine/cisplatin), perioperative durvalumab plus gemcitabine/cisplatin in selected framework, and adjuvant nivolumab or pembrolizumab options in stated postoperative contexts [20]Standard option (per Russian Society of Clinical Oncology / RosOncoWeb)PD-L1 CPS >=1% mentioned for adjuvant nivolumab option after radical cystectomy in source; Curative-intent management for muscle-invasive bladder cancer; neoadjuvant/perioperative and selected adjuvant settings. · Cisplatin eligibility, renal function, performance status, postoperative stage/nodal status, PD-L1 context, timing after cystectomy, and toxicity risks are pathway-defining. This guideline entry does not by itself establish procurement or reimbursement. Confidence/conflicts: High for RUSSCO recommendations; no separate regulator/reimbursement confirmation in this batch. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
Transurethral resection of bladder tumor (TURBT/TUR) plus risk-adapted intravesical therapy including BCG vaccine, or intravesical chemotherapy with doxorubicin, gemcitabine, or mitomycin when BCG is unsuitable [21]Recommended (HTA / guideline)Not biomarker-selected; Initial treatment after diagnosis/staging of non-muscle-invasive bladder cancer; adjuvant intravesical therapy after TUR for intermediate/high-risk groups. · Risk group, muscle presence in pathology, CIS, high-grade status, BCG intolerance/contraindications, recurrence, and very-high-risk features change the pathway; immediate radical cystectomy is discussed for very-high-risk disease. Confidence/conflicts: High for RUSSCO treatment 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. Guideline-recommended standard first-line care for non-muscle-invasive bladder cancer (RUSSCO 2025, EAU 2025, AUA/SUO). TUR is the main diagnostic-and-treatment step; risk-adapted adjuvant intravesical BCG is preferred for intermediate/high-risk disease, with intravesical chemotherapy (mitomycin/gemcitabine/doxorubicin/epirubicin) when BCG is unsuitable; immediate radical cystectomy is considered for very-high-risk disease. The prior 'Not authorised' label was a generator misclassification and is removed. Russian-language primary source — confirm exact wording with your care team. (Note: the line-60393 copy is also mis-filed under category 'supportive' when it is the primary/curative-intent first-line option.)
Transurethral resection of bladder tumor (TURBT/TUR) plus risk-adapted intravesical therapy including BCG vaccine, or intravesical chemotherapy with doxorubicin, gemcitabine, or mitomycin when BCG is unsuitable [21]Recommended (HTA / guideline)Not biomarker-selected; Initial treatment after diagnosis/staging of non-muscle-invasive bladder cancer; adjuvant intravesical therapy after TUR for intermediate/high-risk groups. · Risk group, muscle presence in pathology, CIS, high-grade status, BCG intolerance/contraindications, recurrence, and very-high-risk features change the pathway; immediate radical cystectomy is discussed for very-high-risk disease. Confidence/conflicts: High for RUSSCO treatment 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. Guideline-recommended standard first-line care for non-muscle-invasive bladder cancer (RUSSCO 2025, EAU 2025, AUA/SUO). TUR is the main diagnostic-and-treatment step; risk-adapted adjuvant intravesical BCG is preferred for intermediate/high-risk disease, with intravesical chemotherapy (mitomycin/gemcitabine/doxorubicin/epirubicin) when BCG is unsuitable; immediate radical cystectomy is considered for very-high-risk disease. The prior 'Not authorised' label was a generator misclassification and is removed. Russian-language primary source — confirm exact wording with your care team. (Note: the line-60393 copy is also mis-filed under category 'supportive' when it is the primary/curative-intent first-line option.)
Trimodality / bladder-preserving chemoradiotherapy with radiosensitizing cisplatin, or alternatives including fluorouracil plus mitomycin, carboplatin, or gemcitabine when cisplatin is unsuitable [20]Standard option (per Russian Society of Clinical Oncology / RosOncoWeb)Not biomarker-selected; Bladder-preserving treatment pathway for selected muscle-invasive bladder cancer. · RUSSCO states that surgery alone, radiation alone, or chemotherapy alone are not recommended methods for muscle-invasive bladder cancer because of unsatisfactory results; selection depends on cystectomy eligibility, tumor features, bladder function, cisplatin suitability, and radiation expertise. Confidence/conflicts: High for guideline framework; local radiation capacity and reimbursement not inferred. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
Trimodality / bladder-preserving chemoradiotherapy with radiosensitizing cisplatin, or alternatives including fluorouracil plus mitomycin, carboplatin, or gemcitabine when cisplatin is unsuitable [20]Standard option (per Russian Society of Clinical Oncology / RosOncoWeb)Not biomarker-selected; Bladder-preserving treatment pathway for selected muscle-invasive bladder cancer. · RUSSCO states that surgery alone, radiation alone, or chemotherapy alone are not recommended methods for muscle-invasive bladder cancer because of unsatisfactory results; selection depends on cystectomy eligibility, tumor features, bladder function, cisplatin suitability, and radiation expertise. Confidence/conflicts: High for guideline framework; local radiation capacity and reimbursement not inferred. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.
Trimodality / bladder-preserving chemoradiotherapy with radiosensitizing cisplatin, or alternatives including fluorouracil plus mitomycin, carboplatin, or gemcitabine when cisplatin is unsuitable [20]Standard option (per Russian Society of Clinical Oncology / RosOncoWeb)Not biomarker-selected; Bladder-preserving treatment pathway for selected muscle-invasive bladder cancer. · RUSSCO states that surgery alone, radiation alone, or chemotherapy alone are not recommended methods for muscle-invasive bladder cancer because of unsatisfactory results; selection depends on cystectomy eligibility, tumor features, bladder function, cisplatin suitability, and radiation expertise. Confidence/conflicts: High for guideline framework; local radiation capacity and reimbursement not inferred. Primary source is in Russian. English summary pending human review — confirm exact wording with your care team.

Thailand

Enfortumab vedotin (Padcev) plus pembrolizumab (Keytruda)[22]ApprovedNot biomarker-selected; First-line adult locally advanced or metastatic urothelial cancer in Padcev document; Keytruda document lists locally advanced or metastatic urothelial carcinoma. · NDI prescribing documents support indication text but not reimbursement, local formulary availability, or individual suitability. Earlier Padcev document wording included cisplatin-ineligible patients; newer document includes first-line adult locally advanced/metastatic disease. Confidence/conflicts: High for Thai NDI indication text; exact current wording should use newest product document. Reimbursement not established.
Enfortumab vedotin (Padcev) plus pembrolizumab (Keytruda)[22]ApprovedNot biomarker-selected; First-line adult locally advanced or metastatic urothelial cancer in Padcev document; Keytruda document lists locally advanced or metastatic urothelial carcinoma. · NDI prescribing documents support indication text but not reimbursement, local formulary availability, or individual suitability. Earlier Padcev document wording included cisplatin-ineligible patients; newer document includes first-line adult locally advanced/metastatic disease. Confidence/conflicts: High for Thai NDI indication text; exact current wording should use newest product document. Reimbursement not established.
Erdafitinib (Balversa)[23]ApprovedFGFR3 susceptible genetic alteration in source; FGFR-altered advanced urothelial carcinoma after prior systemic therapy context; exact sequence should be confirmed from current Thai label before patient-facing display. · The fetched NDI text confirms FGFR-altered urothelial/bladder cancer context but exact Thai indication wording should be rechecked in the full PDF; reimbursement and validated FGFR testing access are not established. Confidence/conflicts: Medium-high; Thai NDI source supports FGFR/bladder context, but exact indication sequence requires full-PDF extraction follow-up.
Pembrolizumab (Keytruda) monotherapy [24]ApprovedPD-L1 CPS >=10 applies for cisplatin-ineligible pembrolizumab monotherapy in source; no PD-L1 requirement for platinum-ineligible monotherapy; Cisplatin-ineligible or platinum-ineligible locally advanced/metastatic UC; post-platinum locally advanced/metastatic UC; BCG-unresponsive high-risk NMIBC with CIS where cystectomy is not used. · NDI supports indication text but not reimbursement, PD-L1 testing access, BCG availability, cystectomy candidacy, or patient preference. Confidence/conflicts: High for Thai NDI indication text; payer and testing access not established. Primary source is in Thai. English summary pending human review — confirm exact wording with your care team.
enfortumab vedotin (Padcev)[22]Approvedno biomarker requirement stated in the fetched Padcev monotherapy indication; previously treated locally advanced or metastatic urothelial cancer after both immune-checkpoint inhibitor and platinum-containing chemotherapy exposure. · The label does not provide Thailand reimbursement or center availability in the fetched text. The source is broad mUC rather than UTUC-only, and treatment sequencing after first-line Padcev/pembrolizumab needs specialist review. Confidence/conflicts: High for Thai NDI label text; no conflict identified. Upper-tract-specific evidence and reimbursement are unresolved.
enfortumab vedotin (Padcev) with pembrolizumab (Keytruda)[22]Approvedno biomarker requirement stated for the combination indication in the fetched Thai NDI Padcev label; first-line treatment of adult locally advanced or metastatic urothelial cancer per Padcev label. · The fetched labels are broad urothelial carcinoma and do not separately name renal pelvis or ureter. Thailand reimbursement, hospital formulary availability, and any payer authorization process remain unresolved. Confidence/conflicts: High for Thai NDI label indication text; medium for upper-tract-specific mapping because the labels use broad urothelial-carcinoma language. No conflict identified.
pembrolizumab (Keytruda)[24]ApprovedPD-L1 CPS >=10 for cisplatin-ineligible patients under one Keytruda monotherapy path; no PD-L1 requirement if ineligible for any platinum-containing chemotherapy; no biomarker stated for post-platinum monotherapy path in the fetched label; cisplatin-ineligible first-line monotherapy under PD-L1 or platinum-ineligible conditions; post-platinum locally advanced or metastatic urothelial carcinoma. · The label does not separately identify upper-tract primary sites, and does not resolve access, reimbursement, or whether combination therapy has superseded monotherapy in a given line. PD-L1 testing language applies only to the cisplatin-ineligible/PD-L1 pathway described by the source. Confidence/conflicts: High for Thai NDI Keytruda label indication text; medium for UTUC-specific mapping because the source uses broad urothelial carcinoma. No conflict identified.

출처

U.S. Food and Drug Administration / Drugs@FDA — official prescribing information PDF · official prescribing information PDF
U.S. Food and Drug Administration (FDA) — regulator approval notice · regulator approval notice
National Cancer Institute (NCI) — national cancer agency PDQ / evidence summary · national cancer agency PDQ / evidence summary
U.S. Food and Drug Administration / Drugs@FDA — official prescribing information PDF · official prescribing information PDF
U.S. Food and Drug Administration (FDA) — official drug label · official drug label
U.S. Food and Drug Administration / Drugs@FDA — official prescribing information PDF · official prescribing information PDF
National Cancer Institute (NCI) — national cancer agency evidence summary · national cancer agency evidence summary
U.S. Food and Drug Administration / Drugs@FDA — official prescribing information PDF · official prescribing information PDF
European Medicines Agency (EMA) — regulator EPAR · regulator EPAR
European Medicines Agency (EMA) — regulator EPAR · regulator EPAR
European Medicines Agency (EMA) — regulator EPAR · regulator EPAR
European Medicines Agency (EMA) — EPAR / regulator product page · EPAR / regulator product page
National Institute for Health and Care Excellence (NICE) — technology appraisal guidance · technology appraisal guidance
NHS — national health service patient treatment guidance · national health service patient treatment guidance
National Institute for Health and Care Excellence (NICE) — technology appraisal guidance · technology appraisal guidance
National Institute for Health and Care Excellence (NICE) — technology appraisal guidance · technology appraisal guidance
National Institute for Health and Care Excellence (NICE) — technology appraisal guidance · technology appraisal guidance
Pharmaceuticals and Medical Devices Agency (PMDA) — regulator approved-drug list · regulator approved-drug list
Pharmaceuticals and Medical Devices Agency (PMDA) — regulator safety/indication summary PDF · regulator safety/indication summary PDF
Russian Society of Clinical Oncology (RUSSCO) / RosOncoWeb — professional society clinical recommendations PDF · professional society clinical recommendations PDF
Russian Society of Clinical Oncology (RUSSCO) / RosOncoWeb — professional society clinical recommendations PDF · professional society clinical recommendations PDF
Thai National Drug Information / Thai FDA-MOPH — prescribing information PDF / regulator drug-information repository · prescribing information PDF / regulator drug-information repository
Thai National Drug Information / Thai FDA-MOPH — prescribing information PDF / regulator drug-information repository · prescribing information PDF / regulator drug-information repository
Thai National Drug Information / Thai FDA-MOPH — prescribing information PDF / regulator drug-information repository · prescribing information PDF / regulator drug-information repository

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. 임상 세부 내용은 영문이 정본입니다. 최종 확인 2026-06-12.