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On May 15, 2026, the FDA approved atezolizumab and atezolizumab/hyaluronidase as adjuvant treatment for adults with muscle-invasive bladder cancer after cystectomy who have ctDNA molecular residual disease on an FDA-authorized test, and approved Signatera CDx to select those patients; in IMvigor011 median disease-free survival was 9.9 versus 4.8 months (HR 0.64) and median overall survival was 32.8 versus 21.1 months (HR 0.59).
U.S. FDA
In the phase 3 IMvigor011 trial published in NEJM, 250 of 761 monitored patients with muscle-invasive bladder cancer tested ctDNA-positive after cystectomy and were randomized to atezolizumab or placebo, with median disease-free survival of 9.9 versus 4.8 months (HR 0.64) and median overall survival of 32.8 versus 21.1 months (HR 0.59); persistently ctDNA-negative patients were not treated on study and had a 95% disease-free survival at 1 year.
New England Journal of Medicine
ClinicalTrials.gov lists the observational TiMBER study (NCT07726602), led by OHSU, as recruiting from a June 29, 2026 start date to test whether Labcorp Plasma Detect ctDNA corresponds with recurrence after curative-intent treatment for muscle-invasive urothelial carcinoma.
ClinicalTrials.gov
In a 66-patient retrospective series presented at ASCO GU 2026, baseline Signatera ctDNA positivity before curative-intent treatment for urothelial carcinoma was associated with shorter recurrence-free survival (HR 5.15; 95% CI 1.41 to 18.78).
Journal of Clinical Oncology
On July 10, 2026, the FDA extended perioperative pembrolizumab, or pembrolizumab and berahyaluronidase alfa-pmph, with enfortumab vedotin to adults with muscle-invasive bladder cancer who are candidates for cystectomy, including those eligible for cisplatin; in KEYNOTE-B15/EV-304 (808 patients) event-free survival HR was 0.53 and overall survival HR was 0.65 versus neoadjuvant gemcitabine and cisplatin.
U.S. FDA
In 110 patients with advanced urothelial carcinoma treated with enfortumab vedotin with or without pembrolizumab, an ASCO 2026 analysis of serial Signatera testing associated ctDNA positivity after 12 weeks with worse progression-free survival (HR 36.8) and overall survival (HR 17.7).
Journal of Clinical Oncology
The MolDX billing article A58434, in the revision effective January 1, 2026, lists Signatera for progression, recurrence, or relapse testing in muscle-invasive bladder cancer.
CMS MolDX
On May 28, 2026, the FDA approved durvalumab with BCG for adults with BCG-naive high-risk non-muscle-invasive bladder cancer, based on POTOMAC (1,018 patients), where durvalumab plus BCG induction and maintenance improved investigator-assessed disease-free survival versus BCG alone (HR 0.68; median not reached in either arm).
U.S. FDA
At the NCCN 2026 Annual Conference, enfortumab vedotin plus pembrolizumab was described as the sole preferred first-line regimen in the bladder cancer guideline for locally advanced or metastatic disease.
The ASCO Post
Faculty at the NCCN 2026 Annual Conference described perioperative durvalumab with gemcitabine and cisplatin as the preferred treatment for cisplatin-eligible muscle-invasive bladder cancer.
The ASCO Post
On November 21, 2025, the FDA approved pembrolizumab, or pembrolizumab and berahyaluronidase alfa-pmph, with enfortumab vedotin as neoadjuvant treatment and adjuvant treatment after cystectomy for adults with muscle-invasive bladder cancer who are ineligible for cisplatin; in KEYNOTE-905/EV-303 (344 patients) event-free survival HR was 0.40 and overall survival HR was 0.50 versus surgery alone.
U.S. FDA