What urologists can expect in Q3 of 2025

The third quarter of 2025 is set to be a busy one for urology, continuing with the strong momentum from the first half of the year. With notable approvals across bladder cancer, prostate cancer, and other conditions, 2025 has already cemented itself as a landmark year for urology.

There are several pending FDA decisions and a packed conference season heading into the third quarter.

The first practice-shifting approval came in March 2025 with the approval of perioperative durvalumab (Imfinzi) plus neoadjuvant chemotherapy for muscle-invasive bladder cancer (MIBC). The agency then approved an expanded indication for ¹⁷⁷Lu-PSMA-617 (Pluvicto) in the pre-taxane setting, moving radioligand therapy earlier in the treatment course for metastatic castration-resistant prostate cancer.

In June, the FDA granted notable approvals to mitomycin intravesical solution (Zusduri, formerly UGN-102) for low-grade, intermediate-risk non–muscle invasive bladder cancer (NMIBC) and darolutamide (Nubeqa) without the need for chemotherapy in the metastatic castration-sensitive setting. The agency also approved an expanded label for the Rezūm System in benign prostatic hyperplasia (BPH), raising the maximum prostate volume that can be treated with the water vapor thermal therapy from 80 g to 150 g.

These approvals set the stage for several anticipatory decisions in the third quarter of the year. With several pending FDA decisions and a packed conference season, there is plenty for urologists across all specialties to look out for.

Take a look through the key regulatory decisions and conferences slated for Q3 of 2025.

Regulatory decisions

⁸⁹Zr-DFO-girentuximab (TLX250-CDx; Zircaix)

PDUFA: August 27, 2025

Indication: PET imaging of clear cell renal cell carcinoma

The first regulatory action in Q3 of 2025 will be on the biologics license application (BLA) for ⁸⁹Zr-DFO-girentuximab (TLX250-CDx; Zircaix), for which the FDA is set to have a decision on or by August 27, 2025. If approved, the agent would be indicated for PET imaging of clear cell renal cell carcinoma (ccRCC).

The BLA, which has been granted priority review, is supported by data from the phase 3 ZIRCON trial (NCT03849118). Data from the trial were published in Lancet Oncology,¹ showing that the agent had an average sensitivity of 85.5% (95% CI, 81.5 to 89.6) and an average specificity of 87% (95% CI, 81.0 to 93.1) across 3 independent readers in detecting ccRCC in patients with an indeterminate renal mass (7 cm or smaller).

In discussing the potential impact of ⁸⁹Zr-DFO-girentuximab during an interview with Urology Times®, Jason M. Hafron, MD, likened it to the disruptive influence of PSMA-PET imaging in prostate cancer, saying, “⁸⁹Zr-DFO-girentuximab has the potential to mimic what we've seen in PSMA-PET and prostate cancer with renal cell carcinoma. [It’s] very exciting [and will] potentially [have] a huge impact on the care and management of renal cell carcinoma in the US.”

3-month formulation of leuprolide mesylate (Camcevi; 21 mg)

PDUFA: August 29, 2025

Indication: Adult patients with advanced prostate cancer

Shortly thereafter, the FDA is set to make a decision on the new drug application (NDA) for a 3-month long-acting injectable (LAI) formulation of leuprolide mesylate (Camcevi; 21 mg) for adult patients with advanced prostate cancer. The PDUFA date for the application is August 29, 2025.

The 6-month formulation of leuprolide (42 mg) was previously approved by the FDA in May 2021 for this patient population.

The NDA for the 3-month formulation is supported by findings from an open-label, single-arm, phase 3 trial (NCT03261999) of leuprolide mesylate administered as 2 injections, 3 months apart in patients with advanced prostate cancer.² Overall, the study met its primary end point with 97.9% of patients achieving a serum testosterone concentration suppression to castrate levels (≤ 50 ng/dL) from day 28 through day 168. The 3-month injection was also shown to be safe and well-tolerated in this patient population.³

Subcutaneous pembrolizumab (Keytruda)

PDUFA: September 23, 2025

Indication: All previously approved solid tumor indications

The FDA will then issue a decision on the BLA for subcutaneous (SC) pembrolizumab (Keytruda) on or by September 23, 2025.

Although the supporting data for this application is in non-small cell lung cancer, an approval of SC pembrolizumab with chemotherapy would apply to all previously approved solid tumor indications for the agent, including in genitourinary malignancies. Intravenous (IV) pembrolizumab is currently approved across indications in urothelial carcinoma and renal cell carcinoma.

Overall, the pivotal phase 3 3475A-D77 trial (NCT05722015) met its primary end points by showing non-inferior pharmacokinetics with SC pembrolizumab, with a median injection time of 2 minutes, vs IV pembrolizumab.⁴ Specifically, SC pembrolizumab was non-inferior to IV pembrolizumab regarding the area under the curve exposure of pembrolizumab during the first dosing cycle (geometric mean ratio, 1.14; 96% CI, 1.06 to 1.22; P < .0001) and model-based trough concentration of pembrolizumab measured at steady state (geometric mean ratio, 1.67; 94% CI, 1.52 to 1.84; P < .0001).

SC pembrolizumab also demonstrated consistent results with IV pembrolizumab in the trial’s secondary end points of objective response rate, progression-free survival, duration of response, and safety.

Conferences

Bladder Cancer Advocacy Network (BCAN) Think Tank

Dates: July 30-August 1

Location: Washington DC

The urology scientific meeting season begins to ramp up in Q3, with the 2025 BCAN Think Tank taking place from July 30-August 1 in Washington DC. According to BCAN’s website, “The annual BCAN Bladder Cancer Think Tank Meeting is the premier, annual bladder cancer-specific medical meeting in North America. Since its inception in 2006, the Think Tank meeting has focused on identifying obstacles and creating solutions in bladder cancer research, and has fostered discussions to help define priorities for advancing bladder cancer research. Invited participants include urologists, oncologists, researchers, pathologists, social scientists, patient advocates, and industry representatives, all who are dedicated to improving the diagnosis and treatment of bladder cancer.”

Click here for more information

European Society for Pediatric Urology (ESPU) Joint Meeting

Dates: September 3-6

Location: Vienna, Austria

The ESPU is partnering with several societies, including the Societies for Pediatric Urology and the American Association of Pediatric Urologists, for its annual meeting this year.

View the program here

World Congress of Endourology and Uro-Technology

Dates: September 8-12

Location: Phoenix, Arizona

The preeminent endourology conference is stateside for 2025. The program is chock full of compelling presentations on topics ranging from artificial intelligence, Breakwave Lithotripsy, focal therapy, and much more.

View the program here

Joint Annual Meeting of the International Continence Society and the Emirates Urological Society

Dates: September 17-20, 2025

Location: Abu Dhabi

The International Continence Society and Emirates Urological Society are hosting a joint annual meeting this year. Tracks for the program include Urology, Urogynecology and Female & Functional Urology, Bowel Dysfunction, Pure and Applied Science, and Conservative Management.

View the program here

REFERENCES

1. Shuch B, Pantuck AJ, Bernhard JC, et al. [89Zr]Zr-girentuximab for PET–CT imaging of clear-cell renal cell carcinoma: a prospective, open-label, multicentre, phase 3 trial. Lancet Oncol. 2024;25(10):1277-1287. doi:10.1016/S1470-2045(24)00402-9

2. Safety, efficacy, and pharmacokinetic behavior of leuprolide mesylate (LMIS 25 mg) in subjects with prostate cancer. ClinicalTrials.gov. Last updated May 4, 2020. Accessed June 26, 2025. https://clinicaltrials.gov/study/NCT03261999

3. Foresee Pharmaceuticals announces successful topline results from phase 3 registration study of LMIS 25 mg in prostate cancer. News release. Foresee Pharmaceuticals Co, Ltd. February 21, 2019. Accessed June 26, 2025. https://www.prnewswire.com/news-releases/foresee-pharmaceuticals-announces-successful-topline-results-from-phase-3-registration-study-of-lmis-25-mg-in-prostate-cancer-300799580.html

4. Merck’s investigational subcutaneous pembrolizumab with berahyaluronidase alfa demonstrates noninferior pharmacokinetics compared to intravenous (IV) KEYTRUDA® (pembrolizumab) in pivotal 3475A-D77 trial. News release. Merck. March 27, 2025. Accessed June 26, 2025. https://www.merck.com/news/mercks-investigational-subcutaneous-pembrolizumab-with-berahyaluronidase-alfa-demonstrates-noninferior-pharmacokinetics-compared-to-intravenous-iv-keytruda-pembrolizumab-in-pivotal/