FDA updates in urology: October 2025

Welcome to Urology Times’® monthly FDA update! This month’s notable regulatory decisions reflected the innovation coming down the pike, with a focus on priority reviews, fast track designations, and breakthrough device designations. From advancing next-generation therapeutics for bladder and prostate cancer to progressing minimally invasive technologies for stone disease, these updates underscore the ongoing progress across the spectrum of urologic care.

Stay informed with our FDA recap, delivered during the first week of each new month. To stay even more informed on the latest from Urology Times, subscribe to our newsletters!

FDA News in Urology from October 2025

1. FDA grants fast track designation to EG110A for neurogenic bladder

On October 6, 2025, EG 427 announced that the FDA granted fast track designation to EG110A for the management of neurogenic detrusor overactivity (NDO).¹ This decision followed positive topline results from a phase 1b/2a trial of the agent, showing an over 88% reduction in urinary incontinence episodes at 12 weeks and favorable tolerability in patients with NDO following spinal cord injury.

2. FDA grants priority review to sBLA for EV plus pembrolizumab in cisplatin-ineligible MIBC

On October 22, 2025, Astellas and Merck announced that the FDA granted priority review to 2 supplemental biologics license application for pembrolizumab (Keytruda) and pembrolizumab and berahyaluronidase alfa-pmph (Keytruda QLEX), each in combination with enfortumab vedotin-ejfv (Padcev), as a perioperative regimens for patients with muscle-invasive bladder cancer who are ineligible for cisplatin-based chemotherapy.^2,3 This decision was based on results from the phase 3 KEYNOTE-905/EV-303 trial, showing that the regimen significantly improved event-free survival, overall survival, and pathological complete response rate compared with surgery alone in this patient population. The PDUFA target action date for the application is April 7, 2026.

3. FDA grants fast track designation to pasritamig for mCRPC

On October 15, 2025, Johnson & Johnson announced that the FDA granted fast track designation to pasritamig (JNJ-78278343) for the treatment of patients with metastatic castration-resistant prostate cancer.⁴ Pasritamig is a first-in-class bispecific T-cell–engaging antibody targeting KLK2. This designation came after the presentation of phase 1 data on the agent, which demonstrated PSA reductions of at least 50% in 42% of patients and favorable tolerability.

4. FDA grants Breakthrough Device Designation to Avvio Enhanced Lithotripsy System

On October 28, 2025, Avvio Medical announced that the FDA granted breakthrough device designation to the Avvio Enhanced Lithotripsy System (ELS) for the minimally invasive treatment of ureteral stones.⁵ The Avvio ELS is currently under investigation in a pivotal investigational device exemption study in the US. The designation will facilitate accelerated development and review as Avvio prepares a de novo submission in early 2026.

REFERENCES

1. EG 427 receives U.S. FDA Fast Track Designation for EG110A DNA medicine in neurogenic bladder patients. News release. EG 427. October 6, 2025. Accessed October 6, 2025. https://www.eg427.com/EG-427-Receives-U-S--FDA-Fast-Track-Designation-for-EG110A-DNA-Medicine-in-Neurogenic-Bladder-Patients.html

2. PADCEV™ (enfortumab vedotin-ejfv) Plus KEYTRUDA® (pembrolizumab) sBLA Granted FDA Priority Review for Treatment of Certain Patients with Muscle-Invasive Bladder Cancer. News release. Astellas Pharma, Inc. October 22, 2025. Accessed October 22, 2025. https://newsroom.astellas.com/2025-10-21-PADCEV-TM-enfortumab-vedotin-ejfv-Plus-KEYTRUDA-R-pembrolizumab-sBLA-Granted-FDA-Priority-Review-for-Treatment-of-Certain-Patients-with-Muscle-Invasive-Bladder-Cancer

3. FDA Grants Priority Review for KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph), Each in Combination with Padcev® (enfortumab vedotin-ejfv), for Certain Patients with Muscle-Invasive Bladder Cancer. News release. Merck. October 23, 2025. Accessed October 23, 2025. https://www.merck.com/news/fda-grants-priority-review-for-keytruda-pembrolizumab-and-keytruda-qlex-pembrolizumab-and-berahyaluronidase-alfa-pmph-each-in-combination-with-padcev-enfortumab-vedotin-ejfv/

4. Johnson & Johnson enters new era in solid tumors at ESMO 2025 with promising data across multiple cancer types. News release. Johnson & Johnson. October 15, 2025. Accessed October 21, 2025. https://innovativemedicine.jnj.com/us/news-center/oncology/johnson-johnson-enters-new-era-in-solid-tumors-at-esmo-2025-with-promising-data-across-multiple-cancer-types?sf229310720=1&sf229378866=1

5. Avvio Medical receives FDA Breakthrough Device Designation for the Avvio Enhanced Lithotripsy System (ELS). News release. Avvio Medical, Inc. October 28, 2025. Accessed November 3, 2025. https://www.businesswire.com/news/home/20251028004342/en/Avvio-Medical-Receives-FDA-Breakthrough-Device-Designation-for-the-Avvio-Enhanced-Lithotripsy-System-ELS