November 1st 2025
Among patients with locally advanced/metastatic urothelial cancer who received at least one 2.2 mg/kg dose of BL-B01D1, the confirmed ORR was 44.1%.
October 22nd 2025
Enfortumab vedotin plus pembrolizumab before and after surgery improved EFS vs surgery alone in patients with MIBC in the phase 3 EV-303 trial.
October 17th 2025
Updated results from SunRISe-4 support further investigation of the gemcitabine intravesical system plus cetrelimab in MIBC.
Data from POTOMAC support durvalumab plus BCG and induction and maintenance therapy as a new treatment option in BCG-naive, high-risk NMIBC.
New findings reveal that adding durvalumab to neoadjuvant chemotherapy does not enhance HRQOL in muscle-invasive bladder cancer patients.
Upfront MRI Staging Improves Bladder Cancer-Specific Survival
Using multiparametric MRI for initial staging, then cystoscopic biopsy, improves bladder cancer-specific survival compared with transurethral resection of bladder tumor staging.
Nivolumab Sustains DFS Benefits in Muscle-Invasive Urothelial Carcinoma
Updated results from CheckMate 274 support adjuvant nivolumab as a standard of care for patients with high-risk muscle-invasive urothelial carcinoma.
Atezolizumab Did Not Improve EFS in Non–Muscle-Invasive Bladder Cancer
The safety profile of the atezolizumab with Bacillus Calmette-Guérin in NMIBC was consistent with that of each individual agent.
Intravesical Mitomycin Produces Enduring Efficacy Across NMIBC Trials
Data support the intravesical mitomycin solution’s role as an innovative option for those with recurrent, low-grade, intermediate-risk NMIBC.
Adjuvant Radiation Therapy Improves Local Survival in High-Risk MIBC
No toxicity-related discontinuations were seen with adjuvant radiotherapy among patients with muscle-invasive bladder cancer.
Managing AEs with Gemcitabine Intravesical System in NMIBC
Gary Steinberg, MD, compared the AE profile of the gemcitabine intravesical system for BCG-unresponsive NMIBC with other intravesical therapies.
How Will Gemcitabine Intravesical System Impact BCG-Unresponsive NMIBC?
Gary Steinberg, MD, highlights the FDA approval of the gemcitabine intravesical system and what this means for patients with BCG-unresponsive NMIBC.
FDA Approves Gemcitabine Intravesical System in BCG-Unresponsive NMIBC
In patients who refuse or are ineligible for radical cystectomy, the gemcitabine intravesical system may be given after unsuccessful BCG treatment.
ctDNA Test is Predictive of Adjuvant Atezolizumab Benefit in MIBC
Patients with muscle-invasive bladder cancer with a positive Signatera test displayed a significant improvement in disease-free and overall survival.
TAR-200 Appears Highly Efficacious, Safe in BCG-Unresponsive NMIBC
Results from the SunRISe-1 trial showed that TAR-200 monotherapy achieved a complete response rate of 82.4% in patients with BCG-unresponsive NMIBC.
Enfortumab Vedotin/Pembrolizumab Improves Survival vs Surgery in MIBC
Patients with cisplatin-ineligible bladder cancer who received enfortumab vedotin plus pembrolizumab and surgery had prolonged survival vs those who received surgery alone.
Mitomycin Exhibits Durable Responses in Recurrent, Low-Grade NMIBC
Adverse reactions in the phase 3 ENVISION trial were largely mild to moderate in severity, and serious reactions occurred in 12% of those with NMIBC.
FDA Grants Priority Review to TAR-200 in BCG-Unresponsive High-Risk NMIBC
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.
Patient Enrollment for Phase 3 UGN-103 Trial in LG-IM-NMIBC Complete
The phase 3 UTOPIA trial has enrolled a total of 99 patients with low-grade intermediate-risk NMIBC to receive UGN-103.
AI-Based Urine Test Earns FDA Breakthrough Device Status in Bladder Cancer
Use of the novel artificial intelligence–based test may provide a painless, low-cost alternative in bladder cancer screening.
FDA Grants RMAT Designation to Detalimogene in BCG-Unresponsive NMIBC
Detalimogene voraplasmid demonstrated a 71% anytime CR rate in this non–muscle-invasive bladder cancer population in the phase 1/2 LEGEND trial.
FDA Approves Mitomycin Solution in Low-Grade Intermediate-Risk NMIBC
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.