Bladder & urothelial cancer: guideline history

Anchored to: FDA accelerated approval of enfortumab vedotin (December 2019) and approval of avelumab maintenance (June 2020, JAVELIN Bladder 100)

• addedMetastatic, after platinum and PD-(L)1: Enfortumab vedotin as a category 1 option after platinum chemotherapy and a checkpoint inhibitor.
• addedMetastatic, maintenance after platinum: Avelumab maintenance for patients without progression on first-line platinum chemotherapy.

Anchored to: Annals of Oncology publication, 2022

• addedMetastatic, maintenance after platinum: Avelumab maintenance recommended after platinum-based chemotherapy [I, A; ESMO-MCBS 4].
• addedMuscle-invasive, adjuvant: Adjuvant nivolumab for high-risk disease after cystectomy [I, B].

Anchored to: FDA approvals of enfortumab vedotin with pembrolizumab (December 2023, EV-302) and nivolumab with gemcitabine-cisplatin (March 2024, CheckMate 901)

• recategorisedMetastatic, first line: Enfortumab vedotin plus pembrolizumab becomes the preferred first-line regimen for all patients; platinum chemotherapy moves to other recommended regimens.cisplatin-based chemotherapy preferred → EV plus pembrolizumab preferred (category 1)
• addedMetastatic, cisplatin-eligible, first line: Nivolumab with gemcitabine-cisplatin as an alternative first-line regimen.

Anchored to: FDA approvals of perioperative durvalumab with gemcitabine-cisplatin (March 2025, NIAGARA) and the TAR-200 intravesical gemcitabine system for BCG-unresponsive disease (September 2025, SunRISe-1)

• addedMuscle-invasive, cisplatin-eligible, perioperative: Durvalumab with neoadjuvant gemcitabine-cisplatin, continued after cystectomy.
• addedNon-muscle-invasive, BCG-unresponsive: TAR-200 intravesical gemcitabine system as a bladder-sparing option.