Key FDA decisions urologists can expect in the first half of 2025

There are a number of pending FDA approvals that urologists should keep an eye on as we move through the first half of the year. These include new agents in prostate and bladder cancer, as well as a novel therapeutic for uncomplicated urinary tract infections (uUTIs).

Take a look below at the upcoming regulatory schedule and the data supporting each application.

There are 4 pending approvals in urology for the first half of 2025.

TLX007-CDx in prostate cancer (March 24, 2025)

The first key regulatory decision will be on the new drug application (NDA) for TLX007-CDx, for which the FDA must have a decision on or by March 24, 2025.¹ TLX007-CDx is a cold kit for the preparation of prostate-specific membrane antigen (PSMA)-PET imaging for prostate cancer.

According to Telix Pharmaceuticals, the developer of the agent, TLX007-CDx utilizes “⁶⁸Ga [gallium-68] sourced from both newer high activity generators and cyclotrons powered by the ARTMS QUANTM Irradiation System and GE FASTlab solid and liquid target production system.”¹ The cold kit may enable use of a PSMA imaging product with an extended distribution profile compared with currently approved ⁶⁸Ga PSMA-PET imaging agents, according to the company.

Gepotidacin for uUTIs (March 26, 2025)

It won’t be long after the decision on TLX007-CDx that the FDA will deliver news on gepotidacin, an investigational bactericidal, first-in-class triazaacenaphthylene antibiotic. The Prescription Drug User Fee Act date for the therapeutic is set for March 26, 2025.

In October 2024, the FDA accepted and granted priority review to the NDA for gepotidacin for the treatment of female adults (≥40 kg) and adolescents (≥12 years, ≥40 kg) with uUTIs.² The NDA is supported by data from the phase 3 EAGLE-2 and EAGLE-3 trials.

In EAGLE-2, gepotidacin was found to be noninferior to nitrofurantoin for the management of uUTIs in female adults and adolescents with a uropathogen susceptible to nitrofurantoin. Therapeutic success was achieved in 50.6% of patients in the gepotidacin arm compared with 47.0% in the nitrofurantoin arm (treatment difference 4.3%; 95% CI, -3.6 to 12.1).

Data from EAGLE-3 further supported the efficacy of gepotidacin, demonstrating the superiority of the therapeutic over nitrofurantoin. Specifically, therapeutic success was achieved in 58.5% of patients in the gepotidacin arm vs 43.6% of patients in the nitrofurantoin arm (treatment difference, 14.6%; 95% CI, 6.4 to 22.8).

Durvalumab for MIBC (Q2 of 2025)

We then move to the bladder cancer space. Although a specific date has not been reported, urologists can expect to see an FDA decision on durvalumab (Imfinzi) in the second quarter of 2025. The supplemental biologics license application (sBLA) seeking approval of durvalumab for muscle-invasive bladder cancer (MIBC) was accepted and granted priority review by the FDA in December 2024.³

The sNDA is supported by results from the phase 3 NIAGARA study (NCT03732677), which were presented at the 2024 European Society for Medical Oncology Congress in Barcelona, Spain, and published in The New England Journal of Medicine.^4,5 Overall, data showed that perioperative durvalumab plus neoadjuvant chemotherapy significantly extended event-free survival (EFS) and overall survival (OS) compared with neoadjuvant chemotherapy alone.

Specifically, the estimated EFS at 24-month follow-up was 67.8% in the durvalumab arm vs 59.8% in the chemotherapy alone arm (HR, 0.68; 95% CI, 0.56 to 0.82; P<.001 by stratified log-rank test). Similarly, the estimated overall survival at 24 months was 82.2% in the durvalumab arm compared with 75.2% in the control arm (HR, 0.75; 95% CI, 0.59 to 0.93; P=.01 by stratified log-rank test).

UGN-102 for NMIBC (June 13, 2025)

To wrap up the first half of the year, the FDA is expected to have a decision on UGN-102 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).⁶

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 2024,⁷ 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.

References

1. FDA accepts Telix NDA for new prostate cancer imaging agent. News release. Telix Pharmaceuticals. July 23, 2024. Accessed January 28, 2025. https://telixpharma.com/news-views/fda-accepts-telix-nda-for-new-prostate-imaging-agent/

2. Gepotidacin accepted for priority review by US FDA for treatment of uncomplicated urinary tract infections in female adults and adolescents. News release. GSK. October 16, 2024. Accessed January 28, 2025. https://www.gsk.com/en-gb/media/press-releases/gepotidacin-accepted-for-priority-review-by-us-fda-for-treatment-of-uncomplicated-urinary-tract-infections-in-female-adults-and-adolescents/

3. IMFINZI (durvalumab) granted priority review in the US for patients with muscle-invasive bladder cancer. News release. AstraZeneca. December 6, 2024. Accessed January 28, 2025. https://www.astrazeneca-us.com/media/press-releases/2024/imfinzi-durvalumab-granted-priority-review-in-the-us-for-patients-with-muscle-invasive-bladder-cancer.html

4. Powles TB, van der Heijden MS, Galsky MD, et al. A randomized phase III trial of neoadjuvant durvalumab plus chemotherapy followed by radical cystectomy and adjuvant durvalumab in muscle-invasive bladder cancer (NIAGARA). Presented at: 2024 European Society for Medical Oncology Annual Congress; September 13-17, 2024; Barcelona, Spain. Abstract LBA5. https://cslide.ctimeetingtech.com/esmo2024/attendee/confcal/session/calendar?q=LBA5

5. Powles T, Catto JWF, Galsky MD. Perioperative durvalumab with neoadjuvant chemotherapy in operable bladder cancer. N Engl J Med. 2024;391:1773-1786. doi:10.1056/NEJMoa2408154

6. UroGen announces FDA acceptance of its new drug application for UGN-102. News release. UroGen Pharma Ltd. October 15, 2024. Accessed January 28, 2025. https://investors.urogen.com/news-releases/news-release-details/urogen-announces-fda-acceptance-its-new-drug-application-ugn-102

7. 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 October 16, 2024. https://investors.urogen.com/news-releases/news-release-details/urogen-announces-unprecedented-823-duration-response-12-months