Robert J. Motzer, MD, discusses the significance of the belzutifan plus lenvatinib approval, adverse event management with the combination, and the evolving role of HIF-2α inhibition in ccRCC.
News|Articles|October 1, 2026
FDA updates in urology: September 2026
Author(s)Hannah Clarke
Fact checked by: Benjamin P. Saylor, Strategic Content Lead
A recap of the FDA submissions and regulatory decisions in urology from September 2026.
Advertisement
Advertisement
Welcome to Urology Times’® monthly FDA update! This month’s regulatory news featured new and expanded treatment options in genitourinary oncology, regulatory designations for emerging diagnostic and therapeutic technologies, and clearances for devices used in urologic care. The FDA also addressed drug supply concerns and advanced several investigational programs through expedited regulatory pathways.
Related to this article
Brian Mazzarella, MD, discusses the landscape for intermediate-risk prostate cancer and early VAPOR 2 findings on water vapor ablation.
The phase 3 BiPASS trial is evaluating the use of 68Ga-PSMA-PET in combination with MRI for pre-biopsy prostate cancer detection.
In RTOG 3506, adding enzalutamide to standard ADT and salvage radiotherapy was associated with 2-year PFS benefit.
Armine K. Smith, MD, discusses the importance of integrating sexual health into bladder cancer care, including proactive counseling, preservation strategies, and multidisciplinary support.
In the phase 3 PACE-A trial, SBRT and prostatectomy showed similar 8-year disease control in localized prostate cancer, with lower rates of urinary incontinence after SBRT.
Using PSMA-PET imaging and genomic testing to obtain better information earlier in the disease course changes what clinicians can do with diagnosis and treatment planning.
The registrational study is designed to evaluate the diagnostic performance of 68Ga-DOTA-RM2 vs histopathology in prostate cancer.
Advertisement
Advertisement