Bladder Cancer

Verified discoveries, trials, and approvals for this cancer type. Every story separates evidence strength, regulatory status, and guideline position.

Latest Discoveries

AMBASSADOR trial finds adjuvant pembrolizumab extends disease-free survival in high-risk bladder cancer — not yet FDA-approved for this use

Evidence stage: Later-Stage HumanRegulatory status: Investigational
Cancer type
Bladder Cancer
Published
August 13, 2026

In the randomized, phase 3 AMBASSADOR trial, adjuvant pembrolizumab after radical surgery significantly extended disease-free survival compared with observation alone in patients with high-risk muscle-invasive or locally advanced urothelial carcinoma.…

Primary source cited

Last reviewed

Major Advances

AMBASSADOR trial finds adjuvant pembrolizumab extends disease-free survival in high-risk bladder cancer — not yet FDA-approved for this use

Evidence stage: Later-Stage HumanRegulatory status: Investigational
Cancer type
Bladder Cancer
Published
August 13, 2026

In the randomized, phase 3 AMBASSADOR trial, adjuvant pembrolizumab after radical surgery significantly extended disease-free survival compared with observation alone in patients with high-risk muscle-invasive or locally advanced urothelial carcinoma.…

Primary source cited

Last reviewed

Clinical Trials

Important: Eligibility and enrollment are not guaranteed, and listing here is not a treatment recommendation. Talk to your care team.

AMBASSADOR trial finds adjuvant pembrolizumab extends disease-free survival in high-risk bladder cancer — not yet FDA-approved for this use

Regulatory status: InvestigationalEvidence stage: Later-Stage Human
Cancer type
Bladder Cancer
Trial identifier
10.1056/NEJMoa2401726
View trial details
Study design
Randomized controlled trial
Population
Adults with high-risk muscle-invasive or locally advanced urothelial (bladder) carcinoma, following radical surgical removal of the bladder (radical cystectomy or nephroureterectomy), randomized to adjuvant pembrolizumab or observation alone.
Last reviewed
2026-08-13

Regulatory status by jurisdiction

Unspecified jurisdiction

Status
Investigational
Last verified
2026-08-13

This record has no structured cancer-type scope on file yet — editorial review recommended before treating it as applicable to a specific cancer type.

Primary evidence supporting this story

Eligibility varies — review trial criteria.

FDA Approvals

Regulatory approval is separate from evidence certainty and from guideline position. Approval applies only to the exact indication stated in each jurisdiction record.

FDA approves the first ctDNA-guided adjuvant immunotherapy, for bladder cancer after surgery

Regulatory status: FDA ApprovedEvidence stage: Later-Stage Human
Cancer type
Bladder Cancer
Population
Adults with muscle-invasive bladder cancer (MIBC) who had radical cystectomy with lymph node dissection and had detectable circulating tumor DNA (ctDNA) molecular residual disease (MRD) on serial blood testing within 12 months of surgery, randomized to atezolizumab or placebo, in the randomized, double-blind, phase 3 IMvigor011 trial.
View approval details
Last reviewed
2026-08-13

Regulatory status by jurisdiction

United States (FDA)

Status
FDA-approved for the exact stated cancer/use
Indication
Adults with muscle-invasive bladder cancer after cystectomy who have ctDNA molecular residual disease, as determined by an FDA-authorized test.
Biomarker requirement
Circulating tumor DNA (ctDNA) molecular residual disease, as determined by Signatera CDx
Decision date
2026-05-15

Guideline positions

Guideline

Position
Not addressed
Last verified
2026-08-13

Primary evidence supporting this story

Applies to the exact indication stated.

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Related resources

Trusted resources: official cancer information

CancerDiscoveries summarizes verified records in its database. Absence of a listing here does not establish that a treatment lacks regulatory authorization or access.