What urologists can expect in Q2 of 2025

The second quarter of 2025 comes off the heels of a strong Q1, which welcomed several practice-shifting approvals in the urology space.

Urologists can expect a couple of significant approvals in Q2.

The first of these began with an approval for gepotidacin (Blujepa) for female adults and adolescents with uncomplicated urinary tract infection (uUTI).¹ Gepotidacin marks the first new oral antibiotic for uUTI in nearly 3 decades. Following that approval, the FDA gave the green light to an expanded indication for ¹⁷⁷Lu-PSMA-617 (Pluvicto), moving the use of radioligand therapy earlier in the metastatic castration-resistant prostate cancer treatment paradigm. With ¹⁷⁷Lu-PSMA-617 indicated in the pre-chemotherapy setting, this approval approximately tripled the number of patients eligible to receive this therapeutic, according to Novartis.² We then saw a significant breakthrough in the muscle-invasive bladder cancer space with the FDA approval of perioperative durvalumab (Imfinzi) with neoadjuvant chemotherapy.³ In an interview with Urology Times® following the approval, Matthew D. Galsky, MD, said that the decision, “represents an advance compared to where we've been over the past few decades.”

We now look ahead to what urologists can expect to see in Q2 of 2025. Although the second quarter isn’t slated to be as busy as the first in terms of new approvals, those in the pipeline are similarly expected to make a significant impact on the field.

Regulatory decisions

UGN-102

PFUDA: June 13, 2025

Indication: Low-grade, intermediate risk non–muscle-invasive bladder cancer

The first regulatory action in Q2 will be on the new drug application (NDA) for UGN-102, for which the FDA must have a decision on or by June 13, 2025. The NDA was accepted by the FDA in October 2024, seeking approval of UGN-102 for low-grade, intermediate-risk non–muscle invasive bladder cancer (LG-IR-NMIBC).⁴

The NDA for UGN-102 is backed by findings from the phase 3 ENVISION trial (NCT05243550), which met its primary end point by demonstrating a 79.6% complete response rate in patients with LG-IR-NMIBC at 3 months following the first instillation of the therapy.

Updated data from the trial, which were reported in June 2024,⁵ showed that the estimated 12-month duration of response (DOR) was 82.3% (95% CI, 75.9%, 87.1%) in those patients who achieved a complete response at 3 months following the first instillation (n = 108) of UGN-102. The study also reported a DOR of 80.9% (95% CI, 73.9%–86.2%) at both 15 (n = 43) and 18 (n = 9) months, per a Kaplan-Meier estimate.

Darolutamide plus ADT

PDUFA: Uncertain

Indication: Metastatic hormone-sensitive prostate cancer

Although Bayer hasn’t shared an exact PDUFA date for their supplemental new drug application (sNDA) for darolutamide (Nubeqa) in combination with androgen deprivation therapy (ADT), urologists may likely see a decision as early as the end of Q2/start of Q3. Specifically, the sNDA seeks an expanded indication for darolutamide for use in combination with ADT for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC).⁶

Darolutamide is currently approved in the US in combination with docetaxel for the treatment of adult patients with mHSPC as well as for the treatment of adult patients with non-metastatic castration-resistant prostate cancer.

The sNDA is backed by data from the pivotal phase 3 ARANOTE trial (NCT04736199), which showed that darolutamide plus ADT significantly extended radiological progression-free survival (rPFS) compared with placebo plus ADT in patients with mHSPC. Specifically, at 24 months, the rate of rPFS was 70.3% in the darolutamide arm vs 52.1% in the placebo arm, translating to a 46% reduction in the risk of radiological progression or death (HR, 0.54; 95% CI, 0.41-0.71; P < .0001).

Conferences

Last quarter also started strong in terms of urology-related meetings, with highlights including the Society of Women in Urology 14th Annual Clinical Mentoring Conference, the American Society of Clinical Oncology Genitourinary Cancers Symposium, the Society of Benign Prostate Disease Annual Meeting, the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction Winter Meeting, the American Urological Association (AUA) Advocacy Summit, and the 40th Annual European Association of Urology Congress. Not to be outdone, Q2 marks not only the AUA Annual Meeting but also the American Society of Clinical Oncology Annual Meeting.

American Urological Association 2025 Annual Meeting

Dates: April 26-29, 2025

Location: Las Vegas, Nevada

Upcoming highlights:

The AUA heads to Las Vegas this month for its annual meeting. Taking place at the Venetian Las Vegas, the meeting will be preceded by the AUA Innovation Nexus on April 25. Look for the usual robust program of scientific abstracts, plenary presentations, the P2s: Practice-changing Paradigm-shifting Clinical Trials in Urology, and much more. You can follow Urology Times’ coverage of the meeting here.

View the full program here.

American Society of Clinical Oncology Annual Meeting

Dates: May 30-June 2, 2025

Location: Chicago, Illinois

Upcoming highlights:

As usual, the Windy City plays host to the American Society of Clinical Oncology Annual Meeting. The meeting includes tracks for Kidney and Bladder Cancer as well as Prostate, Testicular, and Penile Cancer. You can follow Urology Times’ coverage of the meeting here.

REFERENCES
1. Blujepa (gepotidacin) approved by US FDA for treatment of uncomplicated urinary tract infections (uUTIs) in female adults and paediatric patients 12 years of age and older. News release. GSK. March 25, 2025. Accessed April 7, 2025. https://www.gsk.com/en-gb/media/press-releases/blujepa-gepotidacin-approved-by-us-fda-for-treatment-of-uncomplicated-urinary-tract-infections/

2. FDA approves Novartis radioligand therapy Pluvicto for earlier use before chemotherapy in PSMA-positive metastatic castration-resistant prostate cancer. News release. Novartis Pharma AG. March 28, 2025. Accessed April 7, 2025. https://www.novartis.com/news/media-releases/fda-approves-novartis-radioligand-therapy-pluvicto-earlier-use-chemotherapy-psma-positive-metastatic-castration-resistant-prostate-cancer

3. FDA approves durvalumab for muscle invasive bladder cancer. News release. US Food & Drug Administration. March 28, 2025. Accessed April 7, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-muscle-invasive-bladder-cancer

4. UroGen announces FDA acceptance of its new drug application for UGN-102. News release. UroGen Pharma Ltd. October 15, 2024. Accessed April 7, 2025. https://investors.urogen.com/news-releases/news-release-details/urogen-announces-fda-acceptance-its-new-drug-application-ugn-102

5. UroGen announces unprecedented 82.3% duration of response at 12 months in the ENVISION trial investigating UGN-102 as potentially the first FDA-approved non-surgical treatment for LG-IR-NMIBC. News release. June 13, 2024. Accessed April 7, 2024. https://investors.urogen.com/news-releases/news-release-details/urogen-announces-unprecedented-823-duration-response-12-months

6. U.S. FDA accepts Supplemental New Drug Application for NUBEQA (darolutamide) for the treatment of patients with metastatic hormone-sensitive prostate cancer. News release. Bayer. November 21, 2024. Accessed April 7, 2025. https://bayer2019tf.q4web.com/news/news-details/2024/U.S.-FDA-Accepts-Supplemental-New-Drug-Application-for-NUBEQA-darolutamide-for-the-Treatment-of-Patients-with-Metastatic-Hormone-Sensitive-Prostate-Cancer/default.aspx