Bladder Cancer

Datopotamab deruxtecan will be assessed alone and in combination with rilvegostomig as adjuvant treatment for patients with high-risk muscle-invasive urothelial carcinoma.

The NDA submission is supported by data from the phase 3 UTOPIA trial.

A claims-based analysis found blue light cystoscopy was associated with increased health care resource use in NMIBC without significantly increasing total costs.

In this episode of The UroOnc Minute, Mark D. Tyson II, MD, MPH, discusses the importance of BCG maintenance therapy in NMIBC and shares strategies for navigating treatment barriers and toxicity.

The registrational trial will compare ivonescimab plus enfortumab vedotin vs pembrolizumab plus enfortumab vedotin for locally advanced or metastatic urothelial carcinoma.

A recap of the FDA submissions and regulatory decisions in urology from July 2026.

Matthew D. Galsky, MD, discusses how the FDA approval of enfortumab vedotin plus pembrolizumab for MIBC is moving the field beyond cisplatin eligibility and influencing future approaches to surgery and response-guided therapy.

Phase 3 BOND-003 data published in Lancet Oncology showed that intravesical cretostimogene grenadenorepvec produced durable complete responses and a favorable safety profile in patients with high-risk, BCG-unresponsive NMIBC with CIS.

Experts discuss why accurately recognizing CIS in patients with suspected NMIBC is essential to preventing disease progression, guiding surveillance, and expanding treatment and clinical trial opportunities.

Can Aydogdu, MD, highlights a study examining the utility of pre-surgical tumor-informed ctDNA to predict pathologic nodal status at radical cystectomy.

The study showed that perioperative EV–pembrolizumab improved EFS, OS, and pCR rate vs neoadjuvant cisplatin-gemcitabine in patients with MIBC who are eligible for cisplatin-based chemotherapy.

Experts discuss practical strategies to improve the detection of CIS through closer urologist-pathologist collaboration, optimized biopsy techniques, and complementary diagnostic tools.

Experts discuss why CIS is frequently underrecognized, highlighting the subtle clinical and cystoscopic features of the disease and the importance of integrating multiple factors to improve detection.

Tyler S. Garman, MD, highlights phase 2 data on intravesical gemcitabine and docetaxel as first-line treatment of BCG-naive NMIBC.

Kathryn H. Gessner, MD, PhD, discusses the current limitations in identifying appropriate candidates for bladder-preserving trimodal therapy, the promise of utDNA, and why shared decision-making remains essential.

Dose interruption rather than discontinuation addresses most gemcitabine intravesical system (Inlexzo) adverse events, with designated champions supporting consistent patient management, according to Elizabeth Mobley, MD.

Elizabeth Mobley, MD, shares practical tips for counseling patients and managing adverse events during treatment with the gemcitabine intravesical system.

Proactive adverse event counseling and a specific hydration protocol are the primary tools for supporting patient retention through the gemcitabine intravesical system's (Inlexzo) extended treatment course, according to Mobley.

Taylor Goodstein, MD, and Matvey Tsivian, MD, discuss how patient selection, staging, and quality-of-life considerations influence early cystectomy decisions in NMIBC.

Enfortumab vedotin-ejfv (Padcev) plus pembrolizumab's (Keytruda) expanded approval shifts the perioperative MIBC conversation from cisplatin eligibility to optimal systemic strategy, according to María Natalia Gandur Quiroga, MD, MSc.

This decision extends the indication for pembrolizumab plus enfortumab vedotin to all patients with MIBC who are candidates for cystectomy.

FDA clearance of the IND for UGN-501 paves the way for a first-in-human phase 1 trial evaluating its safety and feasibility in patients with NMIBC.

Gopa Iyer, MD, reviews early NEXUS-01 data evaluating the investigational anti–Nectin-4 ADC LY4052031, highlighting the importance of CYP2D6-guided dosing to optimize safety.

"Ultimately, integrating robust, disease-specific PROs into routine bladder cancer care represents a key step toward more truly patient-centered management," write the authors.

The NCCN recommends that clinicians consider using ctDNA-MRD testing to stratify risk and guide the use of adjuvant immunotherapy in patients who have not previously received an immune checkpoint inhibitor.