FDA updates in urology: March 2025

Welcome to Urology Times’® monthly FDA update! This month, key developments include the initiation of a pivotal trial in stress urinary incontinence (SUI), an expanded indication for radioligand therapy in metastatic castration-resistant prostate cancer (mCRPC), and the approval of a new treatment regimen in muscle-invasive bladder cancer (MIBC).

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Key updates include a trial in SUI, an expanded indication for radioligand therapy, and a new regimen in MIBC.

FDA news in urology for March 2025

1. FDA greenlights pivotal trial of Voro Urologic Scaffold for postprostatectomy SUI

On March 4, 2025, Levee Medical announced FDA clearance of an investigational device exemption application to initiate the pivotal ARID II trial of the Voro Urologic Scaffold for postprostatectomy SUI. The trial follows promising results from a phase 2 feasibility study and will assess the device’s safety and effectiveness in maintaining bladder neck geometry and urethral length. The scaffold aims to improve continence outcomes for patients undergoing robot-assisted radical prostatectomy.

2. FDA greenlights trial of orellanine in metastatic renal cell carcinoma

On March 18, 2025, Oncorena announced FDA acceptance of an investigational new drug application to initiate the phase 1/2 Oncorella-1 trial of ONC175 (orellanine) for metastatic clear cell or papillary renal cell carcinoma (RCC). The trial, which first launched in Sweden, will assess safety, tolerability, and preliminary anti-tumor effects in patients with RCC who are on dialysis and have exhausted other treatment options. The first US site will be at MD Anderson Cancer Center, led by Professor Nizar Tannir.

3. FDA approves PET imaging product Gozellix for prostate cancer

On March 20, 2025, the FDA approved Gozellix (TLX007-CDx), a proprietary cold kit for the preparation of gallium-68 (68Ga) gozetotide injection, Telix Pharmaceuticals announced. The PET product is indicated for patients with suspected prostate cancer metastases or recurrence. Telix expects Gozellix to enhance PSMA-PET imaging availability and affordability while complementing its first-generation product, Illuccix.

4. FDA approves gepotidacin for uncomplicated UTI

On March 25, 2025, the FDA approved gepotidacin (Blujepa) for the treatment of uncomplicated urinary tract infections (uUTIs) in female adults and adolescents (12 years and older, 40 kg and over), GSK announced. Gepotidacin is the first new oral antibiotic for uUTIs in nearly 30 years. The approval is based on phase 3 trials EAGLE-2 and EAGLE-3, where gepotidacin showed non-inferiority and even superiority to nitrofurantoin, a standard uUTI treatment. GSK plans to launch Blujepa in the US in the second half of 2025.

5. FDA grants marketing authorization to at-home diagnostic test for STIs

On March 28, 2025, the FDA granted de novo marketing clearance to the Visby Medical Women’s Sexual Health Test, the first at-home diagnostic test for chlamydia, gonorrhea, and trichomoniasis. The test delivers results in about 30 minutes without requiring a prescription. The approval was based on clinical data showing high accuracy, with the test able to correctly identify over 97% of positive and negative samples for all 3 infections.

6. FDA approves expanded label for ¹⁷⁷Lu-PSMA-617 in mCRPC

On March 28, 2025, the FDA approved an expanded indication for ¹⁷⁷Lu-PSMA-617 (Pluvicto) to include patients with PSMA-positive mCRPC in the pre-chemotherapy setting. The approval is based on data from the phase 3 PSMAfore trial, which showed that ¹⁷⁷Lu-PSMA-617 significantly prolonged radiographic progression-free survival compared to a change in ARPI. Specifically, the median rPFS was 11.6 months with ¹⁷⁷Lu-PSMA-617 vs 5.6 months with a change in ARPI.

7. FDA approves durvalumab/chemo for muscle–invasive bladder cancer

On March 28, 2025, the FDA approved perioperative durvalumab (Imfinzi) in combination with neoadjuvant chemotherapy for adults with MIBC. The approval was based on findings from the phase 3 NIAGARA trial, which showed that perioperative durvalumab with neoadjuvant chemotherapy significantly improved event-free survival and overall survival compared to neoadjuvant chemotherapy alone. Safety measures were also comparable between both arms.