Intermediate-risk patients could benefit from either intravesical chemotherapy or Bacillus Calmette-Guérin (BCG) instillation, with emerging therapies such as UGN-102 chemoablation showing promise...Moreover, alternative agents such as sequential gemcitabine and docetaxel instillation have demonstrated favorable outcomes in both BCG-naïve and BCG-unresponsive patients...Gene therapy (nadofaragene firadenovec), oncolytic viral therapy (CG0070), interleukin-15 superagonist (Nogapendekin alfa-inbakicept), and innovative drug delivery systems (TAR-200) have shown encouraging clinical potential in this population. This review provides an overview of current intravesical treatment strategies for NMIBC across different risk groups and highlights promising new approaches aimed at overcoming the limitations of BCG therapy.

25 days ago

Review • Journal

IL15 (Interleukin 15)

docetaxel • Adstiladrin (nadofaragene firadenovec-vncg) • Anktiva (nogapendekin alfa inbakicept-pmln) • Inlexzo (gemcitabine intravesical system) • cretostimogene grenadenorepvec (CG0070) • Zusduri (mitomycin intravesicular)

3ms

UTOPIA: A Phase 3 Study of UGN-103 for Treatment of Patients With Low-grade Intermediate-risk Non-muscle Invasive Bladder Cancer (clinicaltrials.gov)

P3, N=99, Active, not recruiting, UroGen Pharma Ltd. | Recruiting --> Active, not recruiting

3 months ago

Enrollment closed

Zusduri (mitomycin intravesicular)

9ms

Novel intravesical delivery systems for nonmuscle invasive bladder cancer. (PubMed, Curr Opin Urol)

Novel intravesical delivery systems show to enhance drug retention, improve tissue penetration, and potentially reduce adverse events. While traditional chemotherapy or BCG remain the gold-standard adjuvant treatments for NMIBC, these novel approaches offer promising alternatives for selected patients pending on ongoing clinical validation.

9 months ago

Journal

FGFR (Fibroblast Growth Factor Receptor)

paclitaxel • Inlexzo (gemcitabine intravesical system) • Oncofid-P (paclitaxel-hyaluronic acid conjugate) • Zusduri (mitomycin intravesicular) • erdafitinib intravesical delivery system (TAR-210)

1year

UTOPIA: A Phase 3 Study of UGN-103 for Treatment of Patients With Low-grade Intermediate-risk Non-muscle Invasive Bladder Cancer (clinicaltrials.gov)

P3, N=87, Recruiting, UroGen Pharma Ltd. | Trial completion date: Mar 2026 --> Jul 2026 | Trial primary completion date: Mar 2025 --> Jul 2025

1 year ago

Trial completion date • Trial primary completion date

Zusduri (mitomycin intravesicular)

over1year

UTOPIA: A Phase 3 Study of UGN-103 for Treatment of Patients With Low-grade Intermediate-risk Non-muscle Invasive Bladder Cancer (clinicaltrials.gov)

P3, N=87, Recruiting, UroGen Pharma Ltd. | Not yet recruiting --> Recruiting

over 1 year ago

Enrollment open

Zusduri (mitomycin intravesicular)

2years

UTOPIA: A Phase 3 Single-arm Study of UGN-103 for Treatment of Patients With Low-grade Intermediate-risk Non-muscle Invasive Bladder Cancer (clinicaltrials.gov)

P3, N=87, Not yet recruiting, UroGen Pharma Ltd.

2 years ago

New P3 trial

Zusduri (mitomycin intravesicular)

over2years

Feasibility of Home Instillation of UGN-102 for Treatment of Low-Grade (LG) Non-Muscle-Invasive Bladder Cancer (NMIBC) (clinicaltrials.gov)

P3, N=8, Completed, UroGen Pharma Ltd. | Active, not recruiting --> Completed | Phase classification: P3b --> P3 | Trial completion date: May 2023 --> Feb 2023

over 2 years ago

Trial completion • Phase classification • Trial completion date

Zusduri (mitomycin intravesicular)

over2years

Treatment of Low-Grade Intermediate-Risk Nonmuscle-Invasive Bladder Cancer with UGN-102 ± Transurethral Resection of Bladder Tumor (TURBT) Compared to TURBT Monotherapy: A Randomized, Controlled, Phase 3 Trial (ATLAS). (PubMed, J Urol)

Primary, non-surgical chemoablation with UGN-102 for the management of LG IR NMIBC offers a potential therapeutic alternative to immediate TURBT monotherapy and warrants further investigation.

over 2 years ago

P3 data • Journal

Zusduri (mitomycin intravesicular)