Bladder Cancer

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

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.

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.

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

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.

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.

This decision marks the first approval of a PD-1 inhibitor plus antibody-drug conjugate regimen in the EU.

Eugene Pietzak, MD, highlights results from a phase 2 study of pembrolizumab plus BCG for patients with very high-risk, BCG-naive high-grade T1 NMIBC who declined upfront radical cystectomy.

Sandip Prasad, MD, discusses 3-year data from the phase 3 ENVISION trial evaluating mitomycin for intravesical solution for recurrent low-grade intermediate-risk non–muscle-invasive bladder cancer.

Abigail Keller shares findings showing that nadofaragene firadenovec is associated with increased urine production during instillation compared with gemcitabine/docetaxel.

The primary end point—12-month DFS rate—was 80% (40/50 evaluable patients; 95% CI, 0.67-0.89), with 2 patients pending assessment and 3 not evaluable.

"Together with the efficacy and safety results, these PRO findings support the overall benefit-risk profile of perioperative EV plus [pembrolizumab] as the new standard of care in this patient population," said Peter H. O'Donnell, MD.

Study investigator Gopa Iyer, MD, concluded that LY4052031 represents a promising next-generation Nectin-4 ADC with a distinct payload mechanism that may overcome EV resistance in mUC.

"These data help inform patient decision-making regarding adjuvant therapy and also point to a possible need for supportive services to help survivors after treatment," said Ronald C. Chen, MD, MPH, FASCO, FASTRO.

At a median follow-up of 42.8 months, median OS was 33.6 months (95% CI, 26.6–39.8) with EV+P (240 events/442 patients) vs 15.9 months (95% CI, 13.6–18.3) with chemotherapy (329 events/444 patients).

"Twenty-seven of 40 patients achieved a pCR amounting to a rate of 68%. Therefore, the null hypothesis could be rejected," said Richard Cathomas, MD.

Christof Vulsteke, MD, PhD, shares in-depth insights on the 3.5-year analysis of the EV-302 trial, evaluating enfortumab vedotin plus pembrolizumab for locally advanced or metastatic urothelial carcinoma.

The approval is supported by data from the phase 3 POTOMAC trial.

The application is supported by data from the phase 3 KEYNOTE-905/EV-303 trial.