What changed: Bladder & urothelial cancer

When this page itself was last checked or edited.

Programme deprioritised after regulatory feedback on Duravelo-2 design

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 preferred)

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)

A milestone in how this cancer is treated.

A milestone in how this cancer is treated.

First-line urothelial cancer with toripalimab, positive phase 3

EFS HR 0.

EFS, OS, and pCR significantly improved (topline; details pending).

DFS HR 0.

DFS HR 0.

A milestone in how this cancer is treated.

Urothelial cancer indication voluntarily withdrawn after TROPiCS-04

FGFR3-altered advanced urothelial cancer after ≥1 systemic therapy incl. PD-1/PD-L1 (full)

CR 75.

EFS HR 0.

CR 82%; 51% in CR at 12 months.

A milestone in how this cancer is treated.

Full approval with pembrolizumab, all first-line advanced urothelial cancer (EV-302)

First-line advanced urothelial cancer with pembrolizumab

OS HR 0.

OS 12.

A milestone in how this cancer is treated.

A milestone in how this cancer is treated.

CR 71%.

A milestone in how this cancer is treated.

HER2-expressing urothelial cancer after platinum

Full approval in metastatic TNBC (ASCENT); accelerated approval in urothelial cancer

HER2+ gastric cancer; HER2-expressing urothelial cancer

DFS HR 0.

A milestone in how this cancer is treated.

Breakthrough Therapy designation, HER2+ urothelial cancer

Maintenance after first-line platinum in advanced urothelial cancer

Low-grade upper tract urothelial carcinoma (mitomycin pyelocalyceal gel)

OS 21.

Pembrolizumab produced complete responses in a substantial minority of patients with BCG-unresponsive carcinoma in situ, about half of them lasting a year or more; approved in January 2020.

A milestone in how this cancer is treated.

Accelerated approval, advanced urothelial cancer after platinum and PD-1/PD-L1 (EV-201)

Advanced urothelial cancer after platinum and PD-1/PD-L1 (accelerated)

FGFR3/2-altered advanced urothelial cancer after platinum (accelerated)

therascreen PIK3CA (tissue and plasma): alpelisib in breast cancer; therascreen FGFR: erdafitinib in urothelial cancer

A milestone in how this cancer is treated.

Urothelial carcinoma (accelerated; later withdrawn 2021)

Merkel cell carcinoma; urothelial cancer after platinum (accelerated)

Locally advanced or metastatic urothelial carcinoma after platinum (accelerated; indication withdrawn 2021)

Complementary PD-L1 assay for durvalumab in urothelial carcinoma

A milestone in how this cancer is treated.

Urothelial carcinoma after platinum (accelerated; later withdrawn)

Urothelial carcinoma (later withdrawn); NSCLC

PD-L1 expression to inform atezolizumab treatment in urothelial carcinoma (later NSCLC)

A milestone in how this cancer is treated.

A milestone in how this cancer is treated.

A milestone in how this cancer is treated.

Cystoscopic detection of non-muscle-invasive papillary bladder cancer, with blue-light cystoscopy

Advanced or metastatic transitional cell carcinoma of the urothelial tract after failure of a platinum-containing regimen

Aid to diagnosis of bladder cancer in patients with haematuria

A milestone in how this cancer is treated.

Monitoring for recurrence in patients with previously diagnosed bladder cancer

Intravesical therapy of BCG-refractory carcinoma in situ of the bladder when immediate cystectomy is not acceptable

Carcinoma in situ of the bladder (TICE BCG)

A milestone in how this cancer is treated.

A milestone in how this cancer is treated.

A milestone in how this cancer is treated.