July 17th 2025
Phase 2b SunRISe-1 trial findings supported the FDA to grant priority review to TAR-200 in BCG-unresponsive high-risk NMIBC with carcinoma in situ.
July 7th 2025
The phase 3 UTOPIA trial has enrolled a total of 99 patients with low-grade intermediate-risk NMIBC to receive UGN-103.
July 1st 2025
Use of the novel artificial intelligence–based test may provide a painless, low-cost alternative in bladder cancer screening.
June 26th 2025
Detalimogene voraplasmid demonstrated a 71% anytime CR rate in this non–muscle-invasive bladder cancer population in the phase 1/2 LEGEND trial.
June 12th 2025
Data from the phase 3 ENVISION trial support the FDA approval of the mitomycin solution for patients with recurrent, low-grade, intermediate-risk NMIBC.
Robust Responses Occur With UGN-102 in Recurrent Intermediate-Risk NMIBC
Data from the ENVISION trial may support UGN-102 as a well-tolerated, efficacious treatment in non–muscle-invasive bladder cancer.
Mitomycin/BCG Combo Shows Similar Efficacy, Reduced BCG Use in NMIBC
A combination of BCG and mitomycin offers a comparable treatment option to BCG monotherapy for NMIBC, potentially lessening the impact of global BCG shortages.
Sasanlimab Combo Poised to Change High-Risk NMIBC Treatment Paradigm
Sasanlimab plus BCG significantly improved event-free survival in BCG-naïve, high-risk NMIBC patients, with notable benefit in carcinoma in situ and T1 tumors.
Chemoimmunotherapy Boosts Pathological Complete Responses in MIBC
Real-world data may support chemotherapy plus immune checkpoint blockade as a promising frontline neoadjuvant therapy for muscle-invasive bladder cancer.
FDA ODAC Votes 5-to-4 Against UGN-102 Intravesical Solution for Bladder Cancer
ODAC has voted against the use of UGN-102 intravesical solution for patients with advanced bladder cancer.
Disitamab Vedotin Combo Extends PFS/OS in HER2+ Urothelial Carcinoma
Treatment with disitamab vedotin and toripalimab improves survival regardless of cisplatin eligibility or HER2 expression level in the phase 3 RC48-C016 trial.
Durvalumab Combo Demonstrates DFS Improvement in High-Risk NMIBC
Data from the POTOMAC trial evaluating durvalumab in NMIBC will be presented at a future medical meeting and shared with global regulatory authorities.
Ileal Free Flap Urethroplasty May Remedy Devastated Bladder Outlet
A new type of robotic posterior surgery has been shown to be a treatment option for patients with devastated bladder outlets.
FDA Issues Refusal to File Letter for Nogapendekin Alfa Inbakicept in NMIBC
The FDA refuses to file the sBLA for nogapendekin alfa inbakicept plus BCG in BCG-unresponsive NMIBC with papillary disease without carcinoma in situ.
UGN-102 Shows Durable Responses, Tolerability in Recurrent Low-Grade NMIBC
Results from the phase 3 ENVISION trial suggest UGN-102 could be a non-surgical alternative to TURBT for recurrent low-grade intermediate-risk NMIBC.
TAR-200 Improves Survival in BCG-Unresponsive, Papillary High-Risk NMIBC
Data from cohort 4 of the phase 2 SunRISe-1 trial demonstrate durable DFS with TAR-200 in BCG-unresponsive, papillary-only, high-risk non–muscle-invasive bladder cancer.
Nogapendekin Alfa Inbakicept Elicits Promising Efficacy in Bladder Carcinoma
Nogapendekin alfa inbakicept plus BCG led to a CR rate of 71%, with 60% of responders maintaining their response for at least 12 months, in patients with bladder carcinoma in situ.
Cretostimogene Grenadenorepvec Displays Efficacy in BCG-Unresponsive NMIBC
Complete response rates were observed consistently across patient subgroups in those with high-risk BCG-unresponsive non-muscle invasive bladder cancer.
PET/CT Lymph Node Staging Doesn't Predict Worse Outcomes After Bladder Cancer Surgery
18F-FDG PET/CT staging of lymph node metastases in patients with bladder cancer undergoing radical cystectomy did not correlate with worse survival outcomes.
Pelvic Radiation Confers More Complications After Bladder Cancer Surgery
Findings may establish a framework for assisting patient counselling and optimizing therapy selection for those undergoing radical cystectomy.
Nadofaragene Firadenovec Yields Responses in BCG-Unresponsive NMIBC
Data from a Japanese trial add to the body of evidence supporting the favorable efficacy and safety of nadofaragene firadenovec for this NMIBC population.
sBLAs Submitted for Nogapendekin Alfa Inbakicept in Lymphopenia/NMIBC
In quarter 1 of 2025, nogapendekin alfa inbakicept received regenerative medicine advanced therapy designation for lymphopenia.
Durvalumab Combo Shows Encouraging Preliminary Data in High-Risk UTUC
Combining durvalumab with chemotherapy produced a good safety profile without increasing surgical risk in the phase 2 iNDUCT-GETUG V08 trial.
FDA Approves Adjuvant Durvalumab/Chemo in Muscle-Invasive Bladder Cancer
Results from the phase 3 NIAGARA trial led to the approval of adjuvant durvalumab/chemotherapy for patients with muscle-invasive bladder cancer after radical cystectomy.
Cretostimogene Grenadenorepvec Yields Sustained Antitumor Activity in NMIBC
No grade 3 or higher treatment-related adverse effects or deaths were reported among those with non-muscle invasive bladder cancer in the BOND-003 trial.
UGN-102 Yields Enduring 18-Month Responses in Low-Grade NMIBC
In patients with low-grade intermediate-risk non-muscle invasive bladder cancer who achieved a CR at 3 months with UGN-102, the 18-month DOR was 80.6%.
Antihistamines Added to IO Associated with Longer Survival in Urothelial Carcinoma
Retrospective analyses found that antihistamines added to atezolizumab yielded a 46% OS rate, a 48% CSS rate, and a 23% PFS rate in patients with metastatic urothelial carcinoma.
EV-302 Supports Enfortumab Vedotin Plus Pembrolizumab as Bladder Cancer SOC
Outcomes observed in the phase 3 EV-302 trial are “transformative” for most patients with advanced or metastatic urothelial carcinoma.
Enfortumab Vedotin Combo Yields ‘Transformative’ Urothelial Cancer Outcomes
Updated findings from the phase 3 EV-302 trial show enduring responses and survival improvements with enfortumab vedotin plus pembrolizumab.
Durable Responses in Low-Grade, Intermediate-Risk NMIBC with UGN-102
Data from the ENVISION and ATLAS trials demonstrated clinically meaningful responses with UGN-102 in the treatment of low-grade, intermediate-risk NMIBC.
Enfortumab Vedotin Combo Improves PFS/OS Vs Chemo in Urothelial Carcinoma
Data from the EV-302 trial support enfortumab vedotin plus pembrolizumab as a new standard of care in frontline urothelial cancer.
Dato-DXd Yields Encouraging Activity in Pretreated Advanced Bladder Cancer
The safety profile of dato-DXd in the phase 1 TROPION-PanTumor01 trial is comparable with prior reports of the agent.
Avelumab Maintenance Extends Survival in Advanced Urothelial Carcinoma, Regardless of Diabetes
Avelumab maintenance demonstrated improved survival outcomes in advanced urothelial carcinoma, including patients with diabetes, in the JAVELIN Bladder 100 study.
Enfortumab Vedotin PFS May Improve Despite Specific AEs in Bladder Cancer
Patients with neuropathy experienced a longer PFS with enfortumab vedotin vs those without neuropathy, skin rash, or hyperglycemia.
Adjuvant Nivolumab Shows Sustained DFS Benefit in High-Risk Bladder Cancer
Data from CheckMate-274 support adjuvant nivolumab as a standard of care in high-risk muscle-invasive urothelial carcinoma.