Urothelial cancer

What changed: Urothelial cancer

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Every dated change on the records linked to Urothelial cancer, newest first: approvals and regulatory steps on its medicines, trials that reported, guideline versions, milestones, and when this page itself was checked. Dates come from the records; none is inferred. Orientation, not medical advice.

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September 2026 · 1

2026-09-23This recordUrothelial cancer
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When this page itself was last checked or edited.

2026 · 1

2026MilestoneUrothelial cancer
Perioperative pembrolizumab plus enfortumab vedotin indication expanded to cisplatin-eligible muscle-invasive bladder cancer
Based on KEYNOTE-B15/EV-304 in 808 patients, a 47% reduction in event-free survival events versus neoadjuvant chemotherapy and surgery.

2025 · 1

2025MilestoneUrothelial cancer
Perioperative pembrolizumab plus enfortumab vedotin approved for cisplatin-ineligible muscle-invasive bladder cancer
Based on KEYNOTE-905/EV-303; approved 21 November 2025.

2024 · 1

2024MilestoneUrothelial cancer
Erdafitinib converted to full FDA approval for FGFR3-altered metastatic urothelial carcinoma
For patients who progressed on at least one prior systemic therapy, approved 19 January 2024.

2023 · 1

2023MilestoneUrothelial cancer
Enfortumab vedotin plus pembrolizumab granted full FDA approval for all locally advanced or metastatic urothelial cancer regardless of cisplatin eligibility
Based on EV-302/KEYNOTE-A39, median overall survival 31.5 versus 16.1 months; approved 15 December 2023.

2022 · 1

2022MilestoneUrothelial cancer
Nadofaragene firadenovec-vncg (Adstiladrin) approved
First gene therapy for BCG-unresponsive non-muscle-invasive bladder cancer with carcinoma in situ, approved 16 December 2022.

2021 · 1

2021MilestoneUrothelial cancer
Nivolumab approved for adjuvant treatment of high-risk urothelial carcinoma after radical resection
Based on CheckMate 274, median disease-free survival 20.8 versus 10.8 months; approved 19-20 August 2021.

2020 · 1

2020MilestoneUrothelial cancer
FDA approved pembrolizumab for BCG-unresponsive, high-risk non-muscle-invasive bladder cancer with carcinoma in situ
Approved 8 January 2020 for patients ineligible for or declining cystectomy.