OnCo
cancersCancer

Bladder & urothelial cancer

Bladder cancer went from 40 years of cisplatin to an ADC-immunotherapy combination that nearly doubled survival, and in 2026 the first blood-test-guided drug approval.

Urothelial carcinoma of the bladder is the tenth most common cancer worldwide and the most expensive to manage per patient, because three quarters present as non-muscle-invasive disease that recurs for years and demands lifelong cystoscopy. Smoking causes about half of cases. Muscle-invasive disease (25%) has required radical cystectomy with neoadjuvant cisplatin since the 2000s, and metastatic disease relied on platinum chemotherapy for four decades.

Between 2019 and 2026 the field was rebuilt. In metastatic disease, enfortumab vedotin plus pembrolizumab nearly doubled survival over chemotherapy (EV-302, 2023). The same pair then moved around surgery: EV-303 in cisplatin-ineligible patients (EFS HR 0.40, approved November 2025) and EV-304 in cisplatin-eligible patients (positive December 2025), after NIAGARA had already established perioperative durvalumab (approved March 2025). Adjuvant nivolumab (CheckMate 274) and ctDNA-guided adjuvant atezolizumab (IMvigor011, the first ctDNA-based approval, 2026) cover the post-cystectomy space. In non-muscle-invasive disease, the BCG-unresponsive population gained four bladder-sparing options (pembrolizumab, nadofaragene firadenovec, N-803 + BCG, and the gemcitabine-eluting device TAR-200), with the oncolytic virus cretostimogene filing in 2026, and durvalumab + BCG became the first systemic immunotherapy in BCG-naive disease (POTOMAC, May 2026). Erdafitinib remains the only targeted drug, for FGFR3-altered tumours after immunotherapy.

What is next: bladder preservation for complete responders to perioperative EV + pembrolizumab; sequencing after EV + pembrolizumab (platinum, HER2 ADCs such as disitamab vedotin, TROP2 and bispecific ADCs, sac-TMT); urine tumour DNA to reduce cystoscopy; resolving BCG shortages with recombinant strains and alternatives; and understanding why some intravesical immunotherapies (durvalumab, sasanlimab) add to BCG while others (atezolizumab) did not.

State of the art today

  • ADC + IO first line.
  • First ctDNA-guided adjuvant approval.
  • EV + pembrolizumab across metastatic, cisplatin-ineligible perioperative (approved 2025), and cisplatin-eligible perioperative (positive 2025) settings.
  • First ctDNA-guided drug approval in any cancer: adjuvant atezolizumab for ctDNA-positive MIBC (IMvigor011, 2026).
  • Five bladder-sparing options for BCG-unresponsive disease, including a drug-eluting device and an oncolytic virus in registration.
  • Durvalumab + BCG: first systemic immunotherapy approved in BCG-naive NMIBC (May 2026).
Show survival figures (2)

Averages across everyone diagnosed, often years ago. Your stage, subtype, age, fitness and the treatment you receive matter more than the average, and the numbers are improving quickly.

  • Perioperative durvalumab (NIAGARA) and adjuvant nivolumab (CheckMate 274) with overall survival benefit.
  • Erdafitinib: the only biomarker-directed targeted therapy, with a survival benefit after immunotherapy.
Who it affects
Show survival figures (1)

Averages across everyone diagnosed, often years ago. Your stage, subtype, age, fitness and the treatment you receive matter more than the average, and the numbers are improving quickly.

  • About 600,000 cases and 220,000 deaths a year worldwide; fourth most common cancer in men in the US; the highest lifetime treatment cost per patient of any cancer.

Where the cases are

Cases by country · GLOBOCAN 2022
All countries →

Site: Bladder. World: 614,298 new cases, 220,596 deaths.

#CountryNew casesDeaths
1China92,88341,367
2United States of America80,40417,705
3Italy34,5808,254
4Japan34,56810,928
5Germany29,0359,180
6United Kingdom23,6436,823
7India22,54812,353
8Spain21,4185,832
9France (metropolitan)19,7337,934
10Russian Federation19,3525,917

Upper-tract urothelial cancers (renal pelvis, ureter) are not included in the bladder site.

Standard of care

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NMIBC

TURBT + intravesical BCG; novel intravesical agents for BCG-unresponsive; durvalumab + BCG for high-risk (2026).

NCCN Guidelines: Bladder Cancer
DurvalumabOncolytic virusesCytokines & engineered cytokines
MIBC

Neoadjuvant chemo ± durvalumab → cystectomy → ctDNA-guided atezolizumab or nivolumab.

NCCN Guidelines: Bladder Cancer
IMvigor011AtezolizumabSignatera
Metastatic

Enfortumab vedotin + pembrolizumab; erdafitinib (FGFR3); platinum + nivolumab.

ESMO-MCBS · 4 (EV-301 enfortumab vedotin); 3 (TROPHY-U-…
EV-302 / KEYNOTE-A39Enfortumab vedotinPembrolizumab
Diagnosis and surveillance

Cystoscopy (white or blue light) and TURBT with muscle in the specimen; re-resection for T1; CT urography; urine cytology; surveillance cystoscopy every 3-12 months by risk.

NCCN · Bladder cancer guideline
Cystoscopy, blue-light imaging & TURBTCT (computed tomography)
Low / intermediate-risk NMIBC

TURBT with single immediate intravesical chemotherapy instillation; intermediate risk adds 1 year of intravesical chemotherapy (gemcitabine/mitomycin) or BCG.

NCCN · 1 (single postoperative instillation)
Cystoscopy, blue-light imaging & TURBTIntravesical therapy (BCG, chemotherapy, devices, gene and viral therapy)
High-risk NMIBC, BCG-naive

TURBT then BCG induction and 1-3 years maintenance; durvalumab + BCG approved May 2026 (POTOMAC); radical cystectomy for very high-risk (T1 + CIS, variant histology).

NCCN · 1 (BCG maintenance); durvalumab + BCG newly…
Intravesical BCGDurvalumabPOTOMACDurvalumab + BCG in BCG-naive high-risk NMIBC
BCG-unresponsive NMIBC (CIS ± papillary)

Radical cystectomy remains the oncologic gold standard; bladder-sparing options: TAR-200 (Inlexzo, 2025), N-803 + BCG (Anktiva, 2024), nadofaragene firadenovec (2022), pembrolizumab (2020); cretostimogene in registration.

NCCN · 2A (intravesical options); cystectomy prefe…
Gemcitabine intravesical system (TAR-200)Nogapendekin alfa inbakiceptNadofaragene firadenovecPembrolizumabCretostimogene grenadenorepvecSunRISe-1BOND-003QUILT 3.032
Muscle-invasive, cisplatin-eligible

Perioperative EV + pembrolizumab (EV-304, positive 2025; filing) or neoadjuvant durvalumab + gemcitabine-cisplatin with adjuvant durvalumab (NIAGARA, approved 2025), then radical cystectomy with lymph node dissection; trimodality bladder preservation (TURBT + chemoradiation) for selected patients.

NCCN · 1 (NIAGARA regimen); EV+pembro pending labelESMO-MCBS · A (NIAGARA)
Enfortumab vedotinPembrolizumabEV-304 / KEYNOTE-B15DurvalumabNIAGARAIMRT / IGRT (modern external beam)Enfortumab vedotin + pembrolizumab across the bladder cancer continuum
Muscle-invasive, cisplatin-ineligible

Perioperative EV + pembrolizumab with cystectomy (EV-303, approved Nov 2025); or cystectomy alone / chemoradiation.

NCCN · 1ESMO-MCBS · A
Enfortumab vedotinPembrolizumabEV-303 / KEYNOTE-905
After cystectomy (no perioperative IO)

Adjuvant nivolumab for high-risk pathology (CheckMate 274); or ctDNA-guided adjuvant atezolizumab (IMvigor011, approved 2026).

NCCN · 1 (nivolumab); ctDNA-guided atezolizumab new
NivolumabCheckMate 274AtezolizumabIMvigor011Signatera
Metastatic, first line

Enfortumab vedotin + pembrolizumab (EV-302); if contraindicated, platinum-gemcitabine followed by avelumab maintenance (JAVELIN Bladder 100) or nivolumab + gemcitabine-cisplatin (CheckMate 901).

NCCN · 1 (preferred: EV + pembrolizumab)ESMO-MCBS · 4
Enfortumab vedotinPembrolizumabEV-302 / KEYNOTE-A39AvelumabJAVELIN Bladder 100Nivolumab
Metastatic, later lines

Erdafitinib if FGFR3-altered (THOR); platinum chemotherapy if not yet given; disitamab vedotin ± toripalimab (HER2, China); sacituzumab govitecan (US indication withdrawn 2024); trials of TROP2/HER2/bispecific ADCs and sac-TMT.

NCCN · 1 (erdafitinib, FGFR3+)
ErdafitinibTHORDisitamab vedotinSacituzumab tirumotecanIzalontamab brengitecanAK146D1

Subtypes & biomarkers

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Subtypes
  • Non-muscle-invasive (Ta, T1, CIS; ~75%)
  • Muscle-invasive (T2-T4; ~25%)
  • Upper-tract urothelial carcinoma (renal pelvis, ureter; ~5-10%)
  • Molecular : luminal-papillary (FGFR3-altered), luminal-infiltrated, basal/squamous, neuroendocrine-like
  • Variant histologies (squamous, micropapillary, plasmacytoid, sarcomatoid, small-cell)
Biomarkers clinicians test

Target prevalence in this cancer

Target / alterationPrevalenceSource
Nectin-4
80-90%
Wikipedia
TROP2
80-90%
PMC
PD-L1
25-30%
Wikipedia
FGFR2
FGFR3 mutations/fusions; erdafitinib
15-20%
cBioPortal (TCGA)

How common each drug target or alteration is in this cancer. Population-level and approximate; see the target page for detail. Full matrix.

History

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  1. 1976BCG immunotherapy for bladder cancer
  2. 1976Morales reports intravesical BCG for bladder cancer
    Intravesical BCG
  3. 1990BCG approved for carcinoma in situ; SWOG maintenance schedule follows (2000)
    Intravesical BCG
  4. 2003SWOG 8710: neoadjuvant MVAC before cystectomy improves survival
  5. 2012Global BCG shortage begins after Sanofi production halt
    Intravesical BCG
  6. 2016Atezolizumab: first new bladder drug in 30 years
  7. 2016Atezolizumab: first new bladder cancer drug in 30 years (later withdrawn)
    Atezolizumab
  8. 2017Pembrolizumab beats chemotherapy in second line (KEYNOTE-045)
    Pembrolizumab
  9. 2019Erdafitinib (first targeted therapy) and enfortumab vedotin (first ADC) approved
    ErdafitinibEnfortumab vedotin
  10. 2020Avelumab maintenance (JAVELIN Bladder 100); pembrolizumab for BCG-unresponsive CIS
    JAVELIN Bladder 100Avelumab
  11. 2021Adjuvant nivolumab (CheckMate 274)
    CheckMate 274
  12. 2022Nadofaragene firadenovec: first bladder gene therapy
    Nadofaragene firadenovec
  13. 2023EV-302 doubles survival
    EV-302 / KEYNOTE-A39
  14. 2023EV-302: EV + pembrolizumab nearly doubles metastatic survival
    EV-302 / KEYNOTE-A39Enfortumab vedotin + pembrolizumab across the bladder cancer continuum
  15. 2024Anktiva (N-803 + BCG) approved; erdafitinib full approval (THOR)
    Nogapendekin alfa inbakiceptTHOR
  16. 2025NIAGARA perioperative durvalumab (March); Inlexzo/TAR-200 (September); EV-303 perioperative EV + pembrolizumab (November); EV-304 positive (December)
    NIAGARAGemcitabine intravesical system (TAR-200)EV-303 / KEYNOTE-905EV-304 / KEYNOTE-B15
  17. 2026IMvigor011: ctDNA-guided atezolizumab approved
    IMvigor011
  18. 2026IMvigor011 ctDNA-guided atezolizumab and POTOMAC durvalumab + BCG approved; cretostimogene BLA under way
    IMvigor011POTOMACCretostimogene grenadenorepvec

Pipeline

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Phase 3Bispecific ADC
Izalontamab brengitecan
Phase 1Bispecific ADC
AK146D1
Not filedADC
Disitamab vedotin
Phase 3Personalised mRNA neoantigen vaccine
Intismeran autogene
Phase 3Oncolytic adenovirus (intravesical)
Cretostimogene grenadenorepvec
ApprovedIntravesical drug-eluting device
Gemcitabine intravesical system (TAR-200) · Inlexzo
Under reviewADC
Sacituzumab tirumotecan
Phase 2Bicycle toxin conjugate (Nectin-4, MMAE)
Zelenectide pevedotin
EV-304 / KEYNOTE-B15BOND-003Bladder preservation for MIBC after perioperative EV + pembrolizumab complete responseUrine tumour DNA to replace surveillance cystoscopy in NMIBCDurvalumab + BCG in BCG-naive high-risk NMIBCEnfortumab vedotin + pembrolizumab across the bladder cancer continuumMRD / molecular residual disease testingCystoscopy, blue-light imaging & TURBT

Open problems

  • BCG supply.
  • Bladder preservation strategies.
  • Nectin-4 ADC resistance.
  • BCG supply remains inadequate a decade after shortages began; alternatives are unproven for BCG-naive high-risk disease.
  • What to give after EV + pembrolizumab fails: platinum rechallenge, HER2 or TROP2 ADCs, and bispecific ADCs are untested in sequence.
  • Whether perioperative therapy's high complete response rates permit bladder preservation in MIBC.
  • Cystoscopic surveillance burden and cost; urine biomarkers not yet guideline-endorsed to replace cystoscopy.
  • Overtreatment risk with systemic immunotherapy (durvalumab + BCG) in a disease many patients survive with BCG alone.
  • Peripheral neuropathy and skin toxicity of enfortumab vedotin limit duration; safer Nectin-4 conjugates stalled in 2026.
  • Upper-tract urothelial carcinoma and variant histologies are under-represented in trials.
  • Only one biomarker (FGFR3) is actionable; HER2 and Nectin-4 selection remain unresolved.

Trials

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Recruiting now (live from ClinicalTrials.gov)

Recruiting trials near you · live from ClinicalTrials.gov
Bladder & urothelial cancer
condition: urothelial carcinoma
Open on ClinicalTrials.gov →

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Landmark trials in OnCo

BOND-003CheckMate 274EV-302 / KEYNOTE-A39EV-303 / KEYNOTE-905EV-304 / KEYNOTE-B15IMvigor011JAVELIN Bladder 100NIAGARAPOTOMACQUILT 3.032SunRISe-1THOR

Expert centres

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Where the expertise is

Centres linked to this cancer in OnCo

Seeking a second opinion: ask your oncologist for a referral to a high-volume centre; most accept records and pathology by mail or telehealth. In the US, use the NCI's Find a Cancer Center tool or the nonprofit Cancer Commons, which navigates options for advanced cancers at no cost.

Questions to ask

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Bring to your appointment

Questions to ask your oncologist about Bladder & urothelial cancer

Generated from this cancer's standard of care, biomarkers, and pipeline · 40 questions

Newly diagnosed

  1. What is my exact diagnosis, stage, and grade, and which tests established them?
    Why: Everything else follows from an accurate stage and subtype.
  2. Which biomarkers have been tested on my tumour (for example FGFR3, PD-L1, HER2, Nectin-4, ctDNA), and what were the results?
    Why: These results decide eligibility for targeted therapy, immunotherapy, and trials.
  3. Which subtype is my cancer, and does that change the recommended treatment?
    Why: Recognised subtypes for this cancer include Non-muscle-invasive, Muscle-invasive, Upper-tract urothelial carcinoma.
  4. Is germline (inherited) genetic testing recommended for me or my family?
    Why: Inherited variants can change treatment and matter for relatives.

NMIBC

  1. For my situation (nmibc), which of the standard options do you recommend and why?
    Why: Guideline options include: TURBT + intravesical BCG; novel intravesical agents for BCG-unresponsive; durvalumab + BCG for high-risk (2026).
  2. Am I a candidate for Durvalumab, and what side effects should I expect?
    Why: Knowing the expected toxicities helps you plan work, family, and supportive care.

MIBC

  1. For my situation (mibc), which of the standard options do you recommend and why?
    Why: Guideline options include: Neoadjuvant chemo ± durvalumab → cystectomy → ctDNA-guided atezolizumab or nivolumab.
  2. Am I a candidate for Atezolizumab, Signatera, and what side effects should I expect?
    Why: Knowing the expected toxicities helps you plan work, family, and supportive care.
  3. How do the results of IMvigor011 apply to someone like me?
    Why: Trial populations differ from individual patients; ask how closely you match.

Metastatic

  1. For my situation (metastatic), which of the standard options do you recommend and why?
    Why: Guideline options include: Enfortumab vedotin + pembrolizumab; erdafitinib (FGFR3); platinum + nivolumab.
  2. Am I a candidate for Enfortumab vedotin, Pembrolizumab, and what side effects should I expect?
    Why: Knowing the expected toxicities helps you plan work, family, and supportive care.
  3. How do the results of EV-302 / KEYNOTE-A39 apply to someone like me?
    Why: Trial populations differ from individual patients; ask how closely you match.

Diagnosis and surveillance

  1. For my situation (diagnosis and surveillance), which of the standard options do you recommend and why?
    Why: Guideline options include: Cystoscopy (white or blue light) and TURBT with muscle in the specimen; re-resection for T1; CT urography; urine cytology; surveillance cystoscopy every 3-12 months by risk.

Low / intermediate-risk NMIBC

  1. For my situation (low / intermediate-risk nmibc), which of the standard options do you recommend and why?
    Why: Guideline options include: TURBT with single immediate intravesical chemotherapy instillation; intermediate risk adds 1 year of intravesical chemotherapy (gemcitabine/mitomycin) or BCG.

High-risk NMIBC, BCG-naive

  1. For my situation (high-risk nmibc, bcg-naive), which of the standard options do you recommend and why?
    Why: Guideline options include: TURBT then BCG induction and 1-3 years maintenance; durvalumab + BCG approved May 2026 (POTOMAC); radical cystectomy for very high-risk (T1 + CIS, variant histology).
  2. Am I a candidate for Intravesical BCG, Durvalumab, and what side effects should I expect?
    Why: Knowing the expected toxicities helps you plan work, family, and supportive care.
  3. How do the results of POTOMAC apply to someone like me?
    Why: Trial populations differ from individual patients; ask how closely you match.

BCG-unresponsive NMIBC (CIS ± papillary)

  1. For my situation (bcg-unresponsive nmibc (cis ± papillary)), which of the standard options do you recommend and why?
    Why: Guideline options include: Radical cystectomy remains the oncologic gold standard; bladder-sparing options: TAR-200 (Inlexzo, 2025), N-803 + BCG (Anktiva, 2024), nadofaragene firadenovec (2022), pembrolizumab (2020); cretostimogene in registration.
  2. Am I a candidate for Gemcitabine intravesical system (TAR-200), Nogapendekin alfa inbakicept, Nadofaragene firadenovec or related drugs, and what side effects should I expect?
    Why: Knowing the expected toxicities helps you plan work, family, and supportive care.
  3. How do the results of SunRISe-1 and BOND-003 apply to someone like me?
    Why: Trial populations differ from individual patients; ask how closely you match.

Muscle-invasive, cisplatin-eligible

  1. For my situation (muscle-invasive, cisplatin-eligible), which of the standard options do you recommend and why?
    Why: Guideline options include: Perioperative EV + pembrolizumab (EV-304, positive 2025; filing) or neoadjuvant durvalumab + gemcitabine-cisplatin with adjuvant durvalumab (NIAGARA, approved 2025), then radical cystectomy with lymph node dissection; trimodality bladder preservation (TURBT + chemoradiation) for selected patients.
  2. Am I a candidate for Enfortumab vedotin, Pembrolizumab, Durvalumab, and what side effects should I expect?
    Why: Knowing the expected toxicities helps you plan work, family, and supportive care.
  3. How do the results of EV-304 / KEYNOTE-B15 and NIAGARA apply to someone like me?
    Why: Trial populations differ from individual patients; ask how closely you match.

Muscle-invasive, cisplatin-ineligible

  1. For my situation (muscle-invasive, cisplatin-ineligible), which of the standard options do you recommend and why?
    Why: Guideline options include: Perioperative EV + pembrolizumab with cystectomy (EV-303, approved Nov 2025); or cystectomy alone / chemoradiation.
  2. Am I a candidate for Enfortumab vedotin, Pembrolizumab, and what side effects should I expect?
    Why: Knowing the expected toxicities helps you plan work, family, and supportive care.
  3. How do the results of EV-303 / KEYNOTE-905 apply to someone like me?
    Why: Trial populations differ from individual patients; ask how closely you match.

After cystectomy (no perioperative IO)

  1. For my situation (after cystectomy (no perioperative io)), which of the standard options do you recommend and why?
    Why: Guideline options include: Adjuvant nivolumab for high-risk pathology (CheckMate 274); or ctDNA-guided adjuvant atezolizumab (IMvigor011, approved 2026).
  2. Am I a candidate for Nivolumab, Atezolizumab, Signatera, and what side effects should I expect?
    Why: Knowing the expected toxicities helps you plan work, family, and supportive care.
  3. How do the results of CheckMate 274 and IMvigor011 apply to someone like me?
    Why: Trial populations differ from individual patients; ask how closely you match.

Metastatic, first line

  1. For my situation (metastatic, first line), which of the standard options do you recommend and why?
    Why: Guideline options include: Enfortumab vedotin + pembrolizumab (EV-302); if contraindicated, platinum-gemcitabine followed by avelumab maintenance (JAVELIN Bladder 100) or nivolumab + gemcitabine-cisplatin (CheckMate 901).
  2. Am I a candidate for Enfortumab vedotin, Pembrolizumab, Avelumab or related drugs, and what side effects should I expect?
    Why: Knowing the expected toxicities helps you plan work, family, and supportive care.
  3. How do the results of EV-302 / KEYNOTE-A39 and JAVELIN Bladder 100 apply to someone like me?
    Why: Trial populations differ from individual patients; ask how closely you match.

Metastatic, later lines

  1. For my situation (metastatic, later lines), which of the standard options do you recommend and why?
    Why: Guideline options include: Erdafitinib if FGFR3-altered (THOR); platinum chemotherapy if not yet given; disitamab vedotin ± toripalimab (HER2, China); sacituzumab govitecan (US indication withdrawn 2024); trials of TROP2/HER2/bispecific ADCs and sac-TMT.
  2. Am I a candidate for Erdafitinib, Disitamab vedotin, Sacituzumab tirumotecan or related drugs, and what side effects should I expect?
    Why: Knowing the expected toxicities helps you plan work, family, and supportive care.
  3. How do the results of THOR apply to someone like me?
    Why: Trial populations differ from individual patients; ask how closely you match.

Any stage

  1. Are there clinical trials I could join, for example of Izalontamab brengitecan, AK146D1, Disitamab vedotin, Intismeran autogene?
    Why: Trials are how the next standard of care is set; asking early keeps options open.
  2. Would a second opinion at a high-volume centre change anything, and can you help arrange it?
    Why: Rare or high-stakes decisions benefit from a centre that treats many similar patients.
  3. What supportive care (symptom control, nutrition, exercise, mental health, financial help) is available from the start?
    Why: Supportive care improves quality of life and helps patients complete treatment.
  4. I read that “BCG supply”. How does that affect my plan?
    Why: Open problems are where trials and second opinions matter most.
  5. I read that “Bladder preservation strategies”. How does that affect my plan?
    Why: Open problems are where trials and second opinions matter most.

Print this page for your appointment (your browser's print command). These prompts are for discussion; your clinical team knows your case.

Everything relevant

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Direct links plus the targets, companies, and technologies of this cancer's products.

technologies

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ADC payload neutralisersAntibody-drug conjugate (ADC)Bispecific ADCCT (computed tomography)Cystoscopy, blue-light imaging & TURBTCytokines & engineered cytokinesCytotoxic chemotherapyEnhanced recovery (ERAS) and perioperative nutritionHIPEC / PIPAC (intraperitoneal chemotherapy)Immune checkpoint inhibitorsIMRT / IGRT (modern external beam)Intravesical therapy (BCG, chemotherapy, devices, gene and viral therapy)Liquid biopsy (ctDNA)MRD / molecular residual disease testingOncolytic virusesPeptide-drug & small-molecule-drug conjugatesPersonalised neoantigen (mRNA) vaccinesPlatinum agentsProbiotics, antibiotics and stewardship around immunotherapyRobotic & minimally invasive surgerySmall-molecule kinase inhibitorsSmoking cessation in cancer patientsTopoisomerase-I inhibitors (and ADC payloads)Trained innate immunity

targets

10
EGFREpCAMFGFR2HER2HER3Nectin-4PD-1PD-L1PRMT5 (MTAP-deleted cancers)TROP2

drugs

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Phase 1Bispecific ADC
AK146D1
ApprovedMonoclonal antibody (anti-PD-L1)
Atezolizumab · Tecentriq / Tecentriq Hybreza (SC)
ApprovedMonoclonal antibody (anti-PD-L1)
Avelumab · Bavencio
NegativeEngineered cytokine (PEGylated IL-2)
Bempegaldesleukin
ApprovedCytotoxic chemotherapy (platinum)
Cisplatin · Platinol (generic)
Phase 3Oncolytic adenovirus (intravesical)
Cretostimogene grenadenorepvec
Not filedADC
Disitamab vedotin
ApprovedMonoclonal antibody (anti-PD-L1)
Durvalumab · Imfinzi
ApprovedADC
Enfortumab vedotin · Padcev
ApprovedSmall-molecule kinase inhibitor (pan-FGFR)
Erdafitinib · Balversa
Not mapped hereNucleoside analogue (deoxycytidine)
Gemcitabine · Gemzar / Infugem
ApprovedIntravesical drug-eluting device
Gemcitabine intravesical system (TAR-200) · Inlexzo
Phase 3Personalised mRNA neoantigen vaccine
Intismeran autogene
Not mapped hereLive bacterial immunotherapy (intravesical)
Intravesical BCG · TICE BCG
Phase 3Bispecific ADC
Izalontamab brengitecan
Not mapped hereAntifolate (DHFR inhibitor)
Methotrexate · Trexall / Otrexup / Xatmep
Not mapped hereAlkylating antibiotic (bioreductive)
Mitomycin C · Mutamycin / Jelmyto / Zusduri
ApprovedNon-replicating adenoviral gene therapy (intravesical)
Nadofaragene firadenovec · Adstiladrin
ApprovedMonoclonal antibody (anti-PD-1)
Nivolumab · Opdivo / Opdivo Qvantig (SC)
ApprovedIL-15 superagonist (intravesical, with BCG)
Nogapendekin alfa inbakicept · Anktiva
ApprovedMonoclonal antibody (anti-PD-1)
Pembrolizumab · Keytruda / Keytruda Qlex (SC)
ApprovedADC
Sacituzumab govitecan · Trodelvy
Under reviewADC
Sacituzumab tirumotecan
EstablishedTumour-informed ctDNA MRD test
Signatera
Not mapped hereVinca alkaloid (microtubule inhibitor)
Vinblastine · Velban
Phase 2Bicycle toxin conjugate (Nectin-4, MMAE)
Zelenectide pevedotin

companies

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AkesoAktis OncologyAstellasAstraZenecaBicycle TherapeuticsBristol Myers SquibbCG OncologyEli Lilly (incl. Loxo)Ferring PharmaceuticalsGenerate:BiomedicinesGilead Sciences (incl. Kite)ImmunityBioJohnson & JohnsonMerck & Co. (MSD)ModernaNateraPfizer (incl. Seagen)RemeGenRoche / GenentechSichuan Kelun-BiotechSystImmune / Sichuan Biokin

institutions

13
ANZUP Cancer Trials GroupCedars-Sinai CancerDana-Farber Brigham Cancer CenterGuy's and St Thomas' NHS Foundation Trust / King's Health Partners Cancer CentreIRCCS Istituto Romagnolo per lo Studio dei Tumori 'Dino Amadori' (IRST)MD Anderson Cancer CenterMemorial Sloan Kettering Cancer CenterNational Cancer Institute, Cairo UniversityOslo University Hospital – The Norwegian Radium HospitalThe Christie NHS Foundation TrustThe Mount Sinai Hospital / Tisch Cancer InstituteUC Davis Comprehensive Cancer CenterUniversity Hospitals Birmingham / University of Birmingham Cancer Research Centre

pathways

3
p53 / RB / cell-cycle checkpointPD-1 / PD-L1 immune checkpoint & T-cell activationRAS / RAF / MEK / ERK (MAPK)

terms

7
BCG-unresponsiveFGFR3 alterations (bladder cancer)Minimal / molecular residual disease (MRD)Neoadjuvant / adjuvant / perioperativeNon-muscle-invasive vs muscle-invasive bladder cancer (NMIBC / MIBC)Pathologic complete response (pCR)TERT promoter mutation

trials

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BOND-003CheckMate 274EV-302 / KEYNOTE-A39EV-303 / KEYNOTE-905EV-304 / KEYNOTE-B15IMvigor011JAVELIN Bladder 100NIAGARAPOTOMACQUILT 3.032SunRISe-1THOR

pairings

4
ADC + checkpoint inhibitorctDNA MRD → adjuvant therapy decisionDurvalumab + BCG in BCG-naive high-risk NMIBCEnfortumab vedotin + pembrolizumab across the bladder cancer continuum

roadmaps

1
TROP2 ADC roadmap: sacituzumab govitecan → Dato-DXd → sac-TMT → bispecifics and PET

ideas

19
A funded programme of organ-preservation trials to avoid radical surgeryA national residual-disease weather service: serial blood tests for every curatively treated patient, pooledA perpetual platform trial in every major cancer, funded as infrastructureA urine DNA test to decide who with blood in the urine needs a camera testAnchor a TGF-beta trap in the tumour stroma so it cannot act everywhereBladder preservation for MIBC after perioperative EV + pembrolizumab complete responseCoverage-with-evidence registries for MR-guided and adaptive radiotherapyMulti-arm, multi-stage trials to answer which order to give approved drugsOncolytic viruses that make interleukin-12 only inside the tumourProtect hearing from cisplatin in adults as we now do in childrenPublic risk-adjusted outcome reporting for cancer surgery to drive centralisationReplace fixed kidney and liver cut-offs with drug-specific, pharmacology-based thresholdsShared concurrent control arms across sponsors' trials in the same settingSlow the tumour's mutation engine with APOBEC inhibitors during targeted therapyTrain the bone marrow to make better anti-tumour immune cellsUrine tumour DNA to replace surveillance cystoscopy in NMIBCUse a blood test at six weeks to decide whether to keep goingUse pre-surgery immunotherapy windows as the field's biomarker engineWatch the immune system's response in the blood three weeks in

people

10
Ananya ChoudhuryDavid B. SolitDingwei YeJae Lyun LeeJames L. GulleyMatthew D. GalskyNicholas JamesPadmanee SharmaPrimo N. Lara Jr.Shilpa Gupta

bottlenecks

5
Biomarkers are not validated or standardisedDormant cells and minimal residual diseaseFunding follows fashion, not burdenNo one can predict who responds to immunotherapySurgery and radiotherapy cure most, get least

key papers

5
EV-302: enfortumab vedotin plus pembrolizumab replaces chemotherapy as first treatment for advanced bladder cancerFifty years of the British Doctors Study: smokers lose ten years of life, quitting gives most of it backIMvigor011: using a blood test for leftover cancer to decide who gets immunotherapy after bladder surgeryNIAGARA: durvalumab before and after cystectomy for muscle-invasive bladder cancerSunRISe-1: TAR-200, a gemcitabine-releasing device placed in the bladder, for BCG-unresponsive non-muscle-invasive bladder cancer

Key papers

5top
rctNew England Journal of Medicine 2025changed practice
IMvigor011: using a blood test for leftover cancer to decide who gets immunotherapy after bladder surgery

After bladder removal, a blood test can now tell who needs immunotherapy and who can safely be spared it. This is the model for MRD-guided adjuvant therapy across cancers: treat the blood-positive, watch the blood-negative.

rctJournal of Clinical Oncology 2025changed practice
SunRISe-1: TAR-200, a gemcitabine-releasing device placed in the bladder, for BCG-unresponsive non-muscle-invasive bladder cancer

Patients with high-risk bladder cancer confined to the lining whose disease has not responded to BCG now have a bladder-sparing option that clears the cancer in most cases, delivered through a simple outpatient procedure. It may allow many to avoid or defer cystectomy, a life-changing operation. Whether responses translate into avoided progression and cystectomy over the long term, and how it compares with cystectomy on survival, remain to be shown.

rctNew England Journal of Medicine 2024changed practice
EV-302: enfortumab vedotin plus pembrolizumab replaces chemotherapy as first treatment for advanced bladder cancer

Almost every patient newly diagnosed with advanced bladder or urothelial cancer should now be offered enfortumab vedotin plus pembrolizumab rather than chemotherapy, with median survival extended from about 16 months to over two and a half years. Neuropathy and skin toxicity need monitoring and dose adjustment, and patients with severe diabetes or pre-existing neuropathy need care. Platinum chemotherapy remains an option for those who cannot receive the combination.

rctNew England Journal of Medicine 2024changed practice
NIAGARA: durvalumab before and after cystectomy for muscle-invasive bladder cancer

Patients fit enough for cisplatin whose bladder cancer has invaded the muscle wall should now be offered durvalumab with their pre-operative chemotherapy and for about a year after surgery, which improves the chance of cure without compromising the operation. The trial cannot say whether the adjuvant phase is necessary, or how to treat cisplatin-ineligible patients, for whom other trials are ongoing.

observationalBMJ 2004changed practice
Fifty years of the British Doctors Study: smokers lose ten years of life, quitting gives most of it back

Smoking is the single largest preventable cause of cancer death, and quitting at any age helps, with the greatest gain from quitting young. Cessation support belongs in every cancer service, including lung screening programmes.

Latest papers

top
Literature trend5 papers in the last 12 monthsHow this is computed
Latest papers · live from Europe PMC
Open in Europe PMC

Query for this cancer: (TITLE:"Bladder & urothelial cancer" OR ABSTRACT:"Bladder & urothelial cancer") AND (treatment OR therapy OR trial OR survival OR diagnosis). Results are unfiltered search hits about Bladder & urothelial cancer, not a curated reading list.

Connected

145top

technologies

19
ADC payload neutralisersAntibody-drug conjugate (ADC)Bispecific ADCCT (computed tomography)Cystoscopy, blue-light imaging & TURBTCytokines & engineered cytokinesEnhanced recovery (ERAS) and perioperative nutritionImmune checkpoint inhibitorsIMRT / IGRT (modern external beam)Intravesical therapy (BCG, chemotherapy, devices, gene and viral therapy)MRD / molecular residual disease testingOncolytic virusesPeptide-drug & small-molecule-drug conjugatesPlatinum agentsProbiotics, antibiotics and stewardship around immunotherapyRobotic & minimally invasive surgerySmall-molecule kinase inhibitorsSmoking cessation in cancer patientsTrained innate immunity

targets

8
EpCAMFGFR2HER2Nectin-4PD-1PD-L1PRMT5 (MTAP-deleted cancers)TROP2

drugs

26
Phase 1Bispecific ADC
AK146D1
ApprovedMonoclonal antibody (anti-PD-L1)
Atezolizumab · Tecentriq / Tecentriq Hybreza (SC)
ApprovedMonoclonal antibody (anti-PD-L1)
Avelumab · Bavencio
NegativeEngineered cytokine (PEGylated IL-2)
Bempegaldesleukin
ApprovedCytotoxic chemotherapy (platinum)
Cisplatin · Platinol (generic)
Phase 3Oncolytic adenovirus (intravesical)
Cretostimogene grenadenorepvec
Not filedADC
Disitamab vedotin
ApprovedMonoclonal antibody (anti-PD-L1)
Durvalumab · Imfinzi
ApprovedADC
Enfortumab vedotin · Padcev
ApprovedSmall-molecule kinase inhibitor (pan-FGFR)
Erdafitinib · Balversa
Not mapped hereNucleoside analogue (deoxycytidine)
Gemcitabine · Gemzar / Infugem
ApprovedIntravesical drug-eluting device
Gemcitabine intravesical system (TAR-200) · Inlexzo
Phase 3Personalised mRNA neoantigen vaccine
Intismeran autogene
Not mapped hereLive bacterial immunotherapy (intravesical)
Intravesical BCG · TICE BCG
Phase 3Bispecific ADC
Izalontamab brengitecan
Not mapped hereAntifolate (DHFR inhibitor)
Methotrexate · Trexall / Otrexup / Xatmep
Not mapped hereAlkylating antibiotic (bioreductive)
Mitomycin C · Mutamycin / Jelmyto / Zusduri
ApprovedNon-replicating adenoviral gene therapy (intravesical)
Nadofaragene firadenovec · Adstiladrin
ApprovedMonoclonal antibody (anti-PD-1)
Nivolumab · Opdivo / Opdivo Qvantig (SC)
ApprovedIL-15 superagonist (intravesical, with BCG)
Nogapendekin alfa inbakicept · Anktiva
ApprovedMonoclonal antibody (anti-PD-1)
Pembrolizumab · Keytruda / Keytruda Qlex (SC)
ApprovedADC
Sacituzumab govitecan · Trodelvy
Under reviewADC
Sacituzumab tirumotecan
EstablishedTumour-informed ctDNA MRD test
Signatera
Not mapped hereVinca alkaloid (microtubule inhibitor)
Vinblastine · Velban
Phase 2Bicycle toxin conjugate (Nectin-4, MMAE)
Zelenectide pevedotin

companies

13
Aktis OncologyAstellasAstraZenecaBicycle TherapeuticsBristol Myers SquibbCG OncologyFerring PharmaceuticalsGenerate:BiomedicinesImmunityBioJohnson & JohnsonMerck & Co. (MSD)Pfizer (incl. Seagen)Roche / Genentech

institutions

13
ANZUP Cancer Trials GroupCedars-Sinai CancerDana-Farber Brigham Cancer CenterGuy's and St Thomas' NHS Foundation Trust / King's Health Partners Cancer CentreIRCCS Istituto Romagnolo per lo Studio dei Tumori 'Dino Amadori' (IRST)MD Anderson Cancer CenterMemorial Sloan Kettering Cancer CenterNational Cancer Institute, Cairo UniversityOslo University Hospital – The Norwegian Radium HospitalThe Christie NHS Foundation TrustThe Mount Sinai Hospital / Tisch Cancer InstituteUC Davis Comprehensive Cancer CenterUniversity Hospitals Birmingham / University of Birmingham Cancer Research Centre

pathways

3
p53 / RB / cell-cycle checkpointPD-1 / PD-L1 immune checkpoint & T-cell activationRAS / RAF / MEK / ERK (MAPK)

terms

7
BCG-unresponsiveFGFR3 alterations (bladder cancer)Minimal / molecular residual disease (MRD)Neoadjuvant / adjuvant / perioperativeNon-muscle-invasive vs muscle-invasive bladder cancer (NMIBC / MIBC)Pathologic complete response (pCR)TERT promoter mutation

trials

12
BOND-003CheckMate 274EV-302 / KEYNOTE-A39EV-303 / KEYNOTE-905EV-304 / KEYNOTE-B15IMvigor011JAVELIN Bladder 100NIAGARAPOTOMACQUILT 3.032SunRISe-1THOR

pairings

4
ADC + checkpoint inhibitorctDNA MRD → adjuvant therapy decisionDurvalumab + BCG in BCG-naive high-risk NMIBCEnfortumab vedotin + pembrolizumab across the bladder cancer continuum

roadmaps

1
TROP2 ADC roadmap: sacituzumab govitecan → Dato-DXd → sac-TMT → bispecifics and PET

ideas

19
A funded programme of organ-preservation trials to avoid radical surgeryA national residual-disease weather service: serial blood tests for every curatively treated patient, pooledA perpetual platform trial in every major cancer, funded as infrastructureA urine DNA test to decide who with blood in the urine needs a camera testAnchor a TGF-beta trap in the tumour stroma so it cannot act everywhereBladder preservation for MIBC after perioperative EV + pembrolizumab complete responseCoverage-with-evidence registries for MR-guided and adaptive radiotherapyMulti-arm, multi-stage trials to answer which order to give approved drugsOncolytic viruses that make interleukin-12 only inside the tumourProtect hearing from cisplatin in adults as we now do in childrenPublic risk-adjusted outcome reporting for cancer surgery to drive centralisationReplace fixed kidney and liver cut-offs with drug-specific, pharmacology-based thresholdsShared concurrent control arms across sponsors' trials in the same settingSlow the tumour's mutation engine with APOBEC inhibitors during targeted therapyTrain the bone marrow to make better anti-tumour immune cellsUrine tumour DNA to replace surveillance cystoscopy in NMIBCUse a blood test at six weeks to decide whether to keep goingUse pre-surgery immunotherapy windows as the field's biomarker engineWatch the immune system's response in the blood three weeks in

people

10
Ananya ChoudhuryDavid B. SolitDingwei YeJae Lyun LeeJames L. GulleyMatthew D. GalskyNicholas JamesPadmanee SharmaPrimo N. Lara Jr.Shilpa Gupta

bottlenecks

5
Biomarkers are not validated or standardisedDormant cells and minimal residual diseaseFunding follows fashion, not burdenNo one can predict who responds to immunotherapySurgery and radiotherapy cure most, get least

key papers

5
EV-302: enfortumab vedotin plus pembrolizumab replaces chemotherapy as first treatment for advanced bladder cancerFifty years of the British Doctors Study: smokers lose ten years of life, quitting gives most of it backIMvigor011: using a blood test for leftover cancer to decide who gets immunotherapy after bladder surgeryNIAGARA: durvalumab before and after cystectomy for muscle-invasive bladder cancerSunRISe-1: TAR-200, a gemcitabine-releasing device placed in the bladder, for BCG-unresponsive non-muscle-invasive bladder cancer