Options mapped

Urothelial / bladder cancer: options by country

Sourced options by country plus visit-prep questions for Urothelial / bladder cancer. Each line links to its regulator, HTA, or guideline source. This page maps options; it does not recommend or rank them.

Options mappedSolid tumorLast checked June 2026

What this page does

Maps options by country

It maps sourced options by country alongside diagnosis wording, stage, test results, specialists, and trial-search terms.

What it does not do

Does not choose treatment

It does not rank treatments, recommend a choice, or decide clinical fit.

Where it comes from

Built on trusted sources

Every option links to a trusted regulator, HTA, or guideline source, and the list grows as new sources pass verification.

Information to gather before the next visit

Is the bladder cancer nonmuscle-invasive, muscle-invasive, locally advanced, or metastatic?
Is bladder preservation possible or is radical cystectomy being discussed?
Would urinary diversion or palliative surgery be for symptom relief?
Is the goal bladder preservation, definitive local control, or palliation?

Trial-search terms to discuss

Urothelial / bladder cancer clinical trial

Options by country

Treatments by country

Regulatory and access status by country, from official sources. It shows what exists and where — not a recommendation.

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.

Sources

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

This is official regulatory and access status only — not medical advice, not a recommendation, and not a statement about eligibility. Whether any option fits depends on your situation and your oncology team. Status changes over time; confirm the current position with the linked source. Last checked 2026-06-12.

Beyond approved care

In clinical trials & emerging options

Options that are not — or not yet — an approved standard where you live: studies, clinical trials, off-label use, and early evidence that your own oncologist may not raise. Each is labeled by how strong the evidence is. A listing here is information to research and discuss with your team; it does not mean a treatment is proven, safe for you, or available today.

In clinical trials

clinical-trial enrollment rather than established radiation or systemic chemotherapy standardClinical trialClinical trialPer NCI PDQUnited States · extensive regional upper tract urothelial cancer. · This is a negative or cautionary option-framing cell, not a claim that radiation or chemotherapy are unavailable. It records that the fetched NCI source does not present a well-established standard-success pathway for extensive regional disease. Confidence/conflicts: High for NCI PDQ regional-disease framing; no conflict identified. National Cancer Institute (NCI) — national cancer agency PDQ / evidence summary
segmental ureteral resection with ureteral reimplantation; selected renal-sparing endoscopic or percutaneous resection/fulguration/laser destructionClinical trialClinical trialPer NCI PDQUnited States · localized superficial distal-third ureter tumor; selected solitary-kidney or reduced-renal-function contexts. · PDQ stresses these options are highly selective and that anything less than total excision carries recurrence risk elsewhere in the upper tract. Endoscopic, percutaneous, and laser approaches are explicitly described as under clinical evaluation. Confidence/conflicts: High for NCI PDQ selective kidney-sparing and distal-ureter criteria; no conflict identified. National Cancer Institute (NCI) — national cancer agency PDQ / evidence summary
enfortumab vedotin plus pembrolizumab versus chemotherapy with cisplatin or carboplatin plus gemcitabineClinical trial · NCT04223856Clinical trialTrial only (NCT04223856)Korea · untreated locally advanced or metastatic urothelial cancer. · Registry site presence does not establish Korean regulator approval, reimbursement, routine access, current enrollment, or individual eligibility. Confidence/conflicts: high for Korea-site registry presence and trial design; no conflict identified. Regulatory access remains separate. ClinicalTrials.gov — clinical-trial registry
erdafitinib versus vinflunine, docetaxel, or pembrolizumabClinical trial · NCT03390504Clinical trialTrial only (NCT03390504)Korea · selected FGFR gene aberrations per registry title; FGFR inhibitor clinical trial assay listed; advanced urothelial cancer with selected FGFR gene aberrations. · Registry evidence does not establish Korean approval or routine access to erdafitinib. Trial enrollment status is active-not-recruiting. Confidence/conflicts: high for Korea-site registry presence and biomarker-trial context; no conflict identified. Regulatory access remains separate. ClinicalTrials.gov — clinical-trial registry
enfortumab vedotin plus pembrolizumab versus chemotherapy with cisplatin or carboplatin plus gemcitabineClinical trial · NCT04223856Clinical trialTrial only (NCT04223856)China · untreated locally advanced or metastatic urothelial cancer. · Registry site presence does not establish NMPA approval, reimbursement, routine availability, current enrollment, or individual eligibility in China. Confidence/conflicts: high for China-site registry presence and trial design; no conflict identified. Regulatory access remains separate. ClinicalTrials.gov — clinical-trial registry
erdafitinib versus vinflunine, docetaxel, or pembrolizumabClinical trial · NCT03390504Clinical trialTrial only (NCT03390504)China · selected FGFR gene aberrations per registry title; FGFR inhibitor clinical trial assay listed; advanced urothelial cancer with selected FGFR gene aberrations. · Registry evidence does not establish NMPA approval, reimbursement, or routine access to erdafitinib in China. Trial enrollment status is active-not-recruiting. Confidence/conflicts: high for China-site registry presence and biomarker-trial context; no conflict identified. Regulatory access remains separate. ClinicalTrials.gov — clinical-trial registry
avelumab plus best supportive care versus best supportive care; post-interim avelumab arm listedClinical trial · NCT02603432Clinical trialTrial only (NCT02603432)Russia · locally advanced or metastatic urothelial cancer; maintenance context is implied by the study title and intervention comparison but regulatory access is not established by the registry. · The registry record is completed and does not establish Russian approval, reimbursement, routine availability, or current access. Confidence/conflicts: high for Russia-site registry presence; no conflict identified. Regulatory access remains separate. ClinicalTrials.gov — clinical-trial registry
enfortumab vedotin plus pembrolizumab versus chemotherapy with cisplatin or carboplatin plus gemcitabineClinical trial · NCT04223856Clinical trialTrial only (NCT04223856)Russia · untreated locally advanced or metastatic urothelial cancer. · Registry site presence does not establish Russian regulator approval, reimbursement, routine access, current enrollment, or individual eligibility. Confidence/conflicts: high for Russia-site registry presence and trial design; no conflict identified. Regulatory access remains separate. ClinicalTrials.gov — clinical-trial registry
enfortumab vedotin plus pembrolizumab versus chemotherapy with cisplatin or carboplatin plus gemcitabineClinical trial · NCT04223856Clinical trialTrial only (NCT04223856)Thailand · untreated locally advanced or metastatic urothelial cancer. · Registry site presence does not establish Thai FDA approval, national reimbursement, routine availability, current enrollment, or individual eligibility. Confidence/conflicts: high for Thailand-site registry presence and trial design; no conflict identified. Regulatory access remains separate. ClinicalTrials.gov — clinical-trial registry

A clinical-trial listing or early report shows an option is being studied — not that it works, that it is safe for any one person, or that a site is enrolling today. Whether any of these fits is a conversation for your oncology team and the trial team. Last checked 2026-06-12.