Bladder Cancer

The FDA granted fast track designation to SBE303, Samsung Bioepis’ investigational Nectin-4–targeting ADC, for advanced urothelial cancer following enfortumab vedotin.

UGN-103, a formulation of intravesical mitomycin as treatment for low-grade intermediate-risk non–muscle-invasive bladder cancer, will receive FDA review with a PDUFA date of June 14, 2027.

FDA expands nogapendekin alfa inbakicept plus BCG use to high-grade papillary–only BCG-unresponsive NMIBC, offering durable control and strong cystectomy-avoidance outcomes.

Durvalumab plus enfortumab vedotin improved EFS and OS in MIBC and will be considered for FDA approval in the fourth quarter of 2026.

In the SURF302 trial, favorable response rates were seen in the single- and multiple-marker-lesion population, justifying further investigation in the adjuvant bladder cancer setting.

AUA/SUO's 2026 NMIBC guideline amendment adds 40 statements on risk stratification, surveillance intervals, urinary biomarkers, and emerging BCG-unresponsive therapies.

UGN-103 NDA targets recurrent low-grade NMIBC; phase 3 UTOPIA reports 77.8% complete response and 94.5% 6-month durability.

Phase 3 results show intravesical cretostimogene drives durable complete responses and bladder preservation in BCG-unresponsive NMIBC.

FDA clears perioperative pembrolizumab plus enfortumab vedotin for muscle-invasive bladder cancer, boosting event-free and overall survival ahead of cystectomy.

FDA clears IND for UGN-501 oncolytic virus, launching phase 1 NMIBC trial to test intravesical safety and immune-driven tumor control.

NCCN adds ctDNA-MRD testing after cystectomy, using Signatera to identify MIBC patients who may benefit from adjuvant atezolizumab.

“In this interim analysis…the response rate with the zelenectide pevedotin and pembrolizumab [was] promising, supporting its benefit-risk profile and supporting…the optimized dosing," said Yohann Loriot, MD, PhD.

“Further investigation of intravesical rBCG in combination with next-generation systemic regimens in randomized trials is warranted,” said Richard Cathomas, MD.

Notably, patients in EV-302 who converted from PR to CR achieved survival outcomes similar to those who achieved CR directly.

The phase 3 POTOMAC study was the supporting trial for the FDA approval of the durvalumab combination for BCG-naive NMIBC.

Durvalumab plus BCG induction/maintenance showed a tolerable safety profile in BCG-naive NMIBC, according to the phase 3b PATAPSCO study.

The sBLA for nogapendekin alfa inbakicept is supported by 36-month follow-up data from cohort B of the QUILT-3.032 trial.

Investigators urge caution in interpreting these results, acknowledging the inherent limitations of unanchored, population-adjusted indirect trial comparisons.

SunRISe-4: Genomic disease burden, TMB, and PD-L1 expression linked to pathologic overall response to neoadjuvant gemcitabine intravesical system plus cetrelimab in MIBC.

The pembrolizumab/BCG combo yielded clinical complete responses at 6 months in over 90% of very high-risk BCG-naive NMIBC patients.

"It's also encouraging that 96.8% of patients were free of progression to muscle-invasive or greater disease,” said Ashish M. Kamat, MD, MBBS.

The FDA approved atezolizumab for the adjuvant treatment of muscle invasive bladder cancer with ctDNA molecular residual disease after cystectomy.

UGN-103 (mitomycin) for intravesical solution sustained disease control through 6 months in the UTOPIA trial in recurrent intermediate-risk LG-NMIBC.