What changed: Bladder & urothelial cancer
Every dated change on the records linked to Bladder & 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.
September 2026 · 1
March 2026 · 1
2026 · 5
- 2026ApprovalNogapendekin alfa inbakiceptNogapendekin alfa inbakicept approved in EU
BCG-unresponsive NMIBC with CIS, with BCG; 16 Feb 2026 (conditional)
- 2026GuidelineBladder & urothelial cancerGuideline NCCN Bladder v3.2026: BCG-unresponsive NMIBC (CIS ± papillary)
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)
- 2026GuidelineBladder & urothelial cancerGuideline NCCN Bladder v3.2026: Diagnosis and surveillance
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)
- 2026MilestoneIMvigor011IMvigor011 ctDNA-guided atezolizumab and POTOMAC durvalumab + BCG approved; cretostimogene BLA under way
A milestone in how this cancer is treated.
- 2026MilestoneIMvigor011IMvigor011: ctDNA-guided atezolizumab approved
A milestone in how this cancer is treated.
December 2025 · 1
2025 · 5
- 2025Trial resultEV-303 / KEYNOTE-905EV-303 / KEYNOTE-905 reported
EFS HR 0.
- 2025Trial resultEV-304 / KEYNOTE-B15EV-304 / KEYNOTE-B15 reported
EFS, OS, and pCR significantly improved (topline; details pending).
- 2025Trial resultIMvigor011IMvigor011 reported
DFS HR 0.
- 2025Trial resultPOTOMACPOTOMAC reported
DFS HR 0.
- 2025MilestoneNIAGARANIAGARA perioperative durvalumab (March); Inlexzo/TAR-200 (September); EV-303 perioperative EV + pembrolizumab (November); EV-304 positive (December)
A milestone in how this cancer is treated.
November 2024 · 1
2024 · 6
- 2024ApprovalErdafitinibErdafitinib approved in US
FGFR3-altered advanced urothelial cancer after ≥1 systemic therapy incl. PD-1/PD-L1 (full)
- 2024ApprovalNogapendekin alfa inbakiceptNogapendekin alfa inbakicept approved in US
BCG-unresponsive NMIBC with CIS ± papillary tumours, with BCG
- 2024Trial resultBOND-003BOND-003 reported
CR 75.
- 2024Trial resultNIAGARANIAGARA reported
EFS HR 0.
- 2024Trial resultSunRISe-1SunRISe-1 reported
CR 82%; 51% in CR at 12 months.
- 2024MilestoneNogapendekin alfa inbakiceptAnktiva (N-803 + BCG) approved; erdafitinib full approval (THOR)
A milestone in how this cancer is treated.
December 2023 · 1
2023 · 5
- 2023ApprovalEnfortumab vedotinEnfortumab vedotin approved in US
First-line advanced urothelial cancer with pembrolizumab
- 2023Trial resultEV-302 / KEYNOTE-A39EV-302 / KEYNOTE-A39 reported
OS HR 0.
- 2023Trial resultTHORTHOR reported
OS 12.
- 2023MilestoneEV-302 / KEYNOTE-A39EV-302 doubles survival
A milestone in how this cancer is treated.
- 2023MilestoneEV-302 / KEYNOTE-A39EV-302: EV + pembrolizumab nearly doubles metastatic survival
A milestone in how this cancer is treated.
2022 · 2
December 2021 · 1
April 2021 · 1
2021 · 3
September 2020 · 1
2020 · 4
- 2020ApprovalAvelumabAvelumab approved in US
Maintenance after first-line platinum in advanced urothelial cancer
- 2020ApprovalMitomycin CMitomycin C approved in US
Low-grade upper tract urothelial carcinoma (mitomycin pyelocalyceal gel)
- 2020Trial resultJAVELIN Bladder 100JAVELIN Bladder 100 reported
OS 21.
- 2020MilestoneJAVELIN Bladder 100Avelumab maintenance (JAVELIN Bladder 100); pembrolizumab for BCG-unresponsive CIS
A milestone in how this cancer is treated.
December 2019 · 1
2019 · 4
- 2019ApprovalEnfortumab vedotinEnfortumab vedotin approved in US
Advanced urothelial cancer after platinum and PD-1/PD-L1 (accelerated)
- 2019ApprovalErdafitinibErdafitinib approved in US
FGFR3/2-altered advanced urothelial cancer after platinum (accelerated)
- 2019Approvaltherascreen companion diagnostic kits (KRAS, EGFR, PIK3CA, FGFR, BRAF)therascreen companion diagnostic kits (KRAS, EGFR, PIK3CA, FGFR, BRAF) approved in US
therascreen PIK3CA (tissue and plasma): alpelisib in breast cancer; therascreen FGFR: erdafitinib in urothelial cancer
- 2019MilestoneErdafitinibErdafitinib (first targeted therapy) and enfortumab vedotin (first ADC) approved
A milestone in how this cancer is treated.
May 2017 · 1
2017 · 4
- 2017ApprovalAvelumabAvelumab approved in US
Merkel cell carcinoma; urothelial cancer after platinum (accelerated)
- 2017ApprovalDurvalumabDurvalumab approved in US
Locally advanced or metastatic urothelial carcinoma after platinum (accelerated; indication withdrawn 2021)
- 2017ApprovalVENTANA PD-L1 (SP263) AssayVENTANA PD-L1 (SP263) Assay approved in US
Complementary PD-L1 assay for durvalumab in urothelial carcinoma
- 2017MilestonePembrolizumabPembrolizumab beats chemotherapy in second line (KEYNOTE-045)
A milestone in how this cancer is treated.
May 2016 · 1
2016 · 4
- 2016ApprovalAtezolizumabAtezolizumab approved in US
Urothelial carcinoma (later withdrawn); NSCLC
- 2016ApprovalVENTANA PD-L1 (SP142) AssayVENTANA PD-L1 (SP142) Assay approved in US
PD-L1 expression to inform atezolizumab treatment in urothelial carcinoma (later NSCLC)
- 2016MilestoneAtezolizumabAtezolizumab: first new bladder cancer drug in 30 years (later withdrawn)
A milestone in how this cancer is treated.
- 2016MilestoneBladder & urothelial cancerAtezolizumab: first new bladder drug in 30 years
A milestone in how this cancer is treated.