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Perioperative durvalumab (Imfinzi) plus neoadjuvant enfortumab vedotin-ejfv (Padcev) cut the risk of EFS events by 49% and death by 42% in cisplatin-ineligible MIBC.

At a median follow-up of 60.9 months, median EFS was 74.1 months in the pembrolizumab arm and not reached in the placebo arm.

This approval expands the perioperative use of pembrolizumab plus enfortumab vedotin to all patients with MIBC, regardless of cisplatin eligibility.

The agency issued a PDUFA target action date of June 14, 2027.

Long-term QUILT-3.032 findings show durable responses with Anktiva plus BCG in BCG-unresponsive NMIBC, with an estimated 84.2% cystectomy-free survival at 3 years.

FDA approves nogapendekin alfa inbakicept plus BCG for papillary-only BCG-unresponsive NMIBC
This approval expands the label for nogapendekin alfa inbakicept to include patients with high-grade papillary-only tumors.

Sandip Prasad, MD, MPhil, discusses ENVISION trial findings on mitomycin for intravesical solution and patient selection in clinical practice.

These FAQs outline key recommendations and practical takeaways from the AUA/SUO guideline amendment on the diagnosis and treatment of NMIBC.

Armine K. Smith, MD, discusses the importance of integrating sexual health into bladder cancer care, including proactive counseling, preservation strategies, and multidisciplinary support.

One year following the approval of the gemcitabine intravesical system, Joseph Jacob, MD, reflects on the expanding treatment landscape in BCG-unresponsive NMIBC.

The PDUFA target action date is in the fourth quarter of 2026.

Sandip Prasad, MD, discusses patient selection for chemoablation in recurrent LG-IR-NMIBC and considerations when counseling patients about a nonsurgical approach.

Enfortumab vedotin-ejfv (Padcev) plus pembrolizumab (Keytruda) showed the strongest EFS, OS, and pCR associations among neoadjuvant MIBC strategies in a network meta-analysis, although perioperative design limits attribution.

Sandip Prasad, MD, MPhil, discusses the evolving role of chemoablation in recurrent low-grade, intermediate-risk NMIBC, including patient selection and treatment considerations.

Eugene Cone, MD, discusses recombinant BCG for NMIBC, including ongoing clinical evaluation and its potential to address ongoing BCG supply challenges.

A decision is expected by the fourth quarter of 2026.

Eugene Cone, MD, discusses SWOG S1602 findings comparing Tokyo-172 and TICE BCG and the potential role of alternative BCG strains in NMIBC

Eugene Cone, MD, discusses the impact of ongoing BCG supply challenges and the potential role of alternative and recombinant strains for NMIBC care.

All patients have been treated in the phase 3 ENLIGHTED trial, evaluating padeliporfin VTP for low-grade upper tract urothelial carcinoma.

John P. Sfakianos, MD, discusses the challenges of managing recurrent LG-IR-NMIBC and the role of chemoablation.

Dabogratinib showed early activity and manageable safety in FGFR3-altered LG-IR-NMIBC, supporting advancement to a planned registrational study in the adjuvant setting.

Advocacy through groups like BCAN and the AUA shapes urologic oncology policy—driving funding, screening access, and equity in cancer care, the authors write.

NeoBLAST, a phase 2/3 Canadian trial, tests whether active surveillance can safely replace surgery/radiation in patients with MIBC with complete response to neoadjuvant therapy.

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

Emanuele Crupi, MD, discusses prospective data supporting GemFLP as a benchmark for treatment of advanced urachal and non-urachal urinary tract adenocarcinomas.
































