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"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.

Vesta Bladder Risk Stratify Dx applies AI foundation models to H&E pathology slides obtained during routine clinical care to generate prognostic risk assessments.

The agency issued a PDUFA target action date of January 6, 2027.



"I think these data clearly support one year of durvalumab in combination with induction maintenance BCG as a potential new treatment for patients with BCG high-risk NMIBC with the appropriate shared decision-making conversation," said Neal D. Shore, MD, FACS.

The agency simultaneously approved the Signatera CDx as a companion diagnostic to identify patients with ctDNA MRD who are eligible for treatment.


A comprehensive guide to the practice-changing, paradigm-shifting studies across urologic oncology.

Maria Carmen Mir, MD, PhD, discusses how phase 3 trials of BCG/ICI combinations are shaping the future of high-risk NMIBC management, emphasizing the need for a more selective approach to treatment intensification.


The safety profile for BCG–gem/doce was favorable, which the authors suggested may “potentially increase compliance with maintenance regimens.”


Song Jiang, MD, PhD, discusses the balance between efficacy and safety data when considering the role for BCG/ICI combinations in BCG-naive NMIBC.

Neoadjuvant sacituzumab govitecan plus pembrolizumab yielded a clinical complete response rate of 39%, supporting the potential for bladder preservation.

In this video, Meri-Margaret Deoudes discusses ongoing challenges for patients with bladder cancer, including costs of care, delayed diagnoses among women, and access barriers among patients in rural areas.

The FDA granted priority review to EV plus pembrolizumab as a perioperative regimen for cisplatin-eligible MIBC based on KEYNOTE-B15 data showing a 47% reduction in EFS events, a 35% reduction in the risk of death, and a pCR rate of 55.8% vs 32.5% with standard chemotherapy.

"Parastomal hernia repair can be performed either open or robotically, according to the surgeon’s preference. The 2 mainstays of repair are the keyhole and intraperitoneal Sugarbaker repairs," Wyre writes.

Adding pembrolizumab to trimodality therapy demonstrated encouraging activity in patients with muscle-invasive bladder cancer.

Meri-Margaret Deoudes discusses findings from BCAN's New Faces of Bladder Cancer Report.

The findings highlight the potential of field-effect-informed liquid biopsy methods to guide adjuvant treatment decisions in NMIBC.





































