FDA updates in urology: June 2025

Welcome to Urology Times’® monthly FDA update! June was a busy month for urological regulatory news, featuring new approvals for prostate cancer, bladder cancer, benign prostatic hyperplasia (BPH), and incontinence. Additionally, notable advancements were made in the development of an oral antibiotic for uncomplicated gonorrhea, a theranostic radiopharmaceutical in prostate cancer, and a gene-based immunotherapy in bladder cancer.

This month saw notable advancements across prostate cancer, bladder cancer, BPH, and incontinence.

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FDA News in Urology for June 2025

1. FDA authorizes Expanded Access Program of Anktiva for lymphopenia

On June 2, 2025, ImmunityBio announced FDA authorization of an Expanded Access Program for nogapendekin alfa inbakicept-pmln (Anktiva) to manage lymphopenia in adults with relapsed or refractory solid tumors, including genitourinary cancers. Data from the phase 2 QUILT-88 trial and additional data presented at the 2025 American Society of Clinical Oncology Annual Meeting showed that the Anktiva-based Cancer BioShield platform led to a survival benefit and lymphocyte restoration in heavily pretreated patients with pancreatic cancer. The platform received RMAT designation earlier in 2025 for this novel immunorestorative approach.

2. FDA approves darolutamide in metastatic castration-sensitive prostate cancer

On June 3, 2025, Bayer announced that the FDA approved darolutamide (Nubeqa) for the treatment of adult patients with metastatic castration-sensitive prostate cancer (mCSPC). The approval is supported by results from the phase 3 ARANOTE trial (NCT04736199), which found that darolutamide plus androgen deprivation therapy (ADT) significantly improved radiographic progression-free survival compared with ADT alone. This approval makes darolutamide the first androgen receptor inhibitor indicated for mCSPC with or without chemotherapy.

3. FDA accepts new drug application for zoliflodacin for uncomplicated gonorrhea

On June 10, 2025, Innoviva Specialty Therapeutics announced FDA acceptance of a new drug application (NDA) for zoliflodacin, a first-in-class oral antibiotic for uncomplicated gonorrhea in patients aged 12 and older. The NDA is supported by data from a phase 3 trial (NCT03959527), which demonstrated that zoliflodacin was non-inferior to the standard ceftriaxone/azithromycin regimen in microbiological cure rates at urogenital and extragenital sites. The application has a PDUFA target action date of December 15, 2025.

4. FDA approves label expansion for Rezūm Water Vapor Thermal Therapy for BPH

On June 11, 2025, the FDA cleared a 510(k) label expansion for the Rezūm System, raising the maximum prostate volume that can be treated with the device from 80 g to 150 g for patients with BPH.The expanded indication is supported by a meta-analysis and prospective trial data showing comparable safety and efficacy of Rezūm Water Vapor Thermal Therapy in larger glands.

5. FDA approves mitomycin intravesical solution for recurrent LG-IR-NMIBC

On June 12, 2025, UroGen announced FDA approval of mitomycin for intravesical solution (Zusduri; formerly UGN-102) for the treatment of adult patients with recurrent low-grade intermediate-risk non–muscle invasive bladder cancer (LG-IR-NMIBC). The approved was backed by results from the phase 3 ENVISION trial (NCT05243550), which demonstrated a 78% complete response rate at 3 months and durable responses through 18 months. This marks the first FDA-approved medication in this disease setting.

6. FDA does not approve talazoparib plus enzalutamide for non-HRR gene mutated mCRPC

On June 13, 2025, Pfizer announced that the FDA declined to approve expanded labeling for talazoparib (Talzenna) plus enzalutamide (Xtandi) to include use in non–HRR gene-mutated metastatic castration-resistant prostate cancer (mCRPC). Overall, the agency sided with a negative decision from the Oncologic Drugs Advisory Committee, determining that data from the phase 3 TALAPRO-2 trial (NCT03395197) were insufficient to support expanded use in this indication. However, the agency did approve updated labeling for the combination’s existing indication to reflect final OS results in HRR gene-mutated mCRPC.

7. FDA approves integrated sacral neuromodulation system for urinary urge incontinence

On June 18, 2025, Neuspera Medical announced FDA clearance of its integrated sacral neuromodulation system for the treatment of patients with urinary urge incontinence (UUI). The approval is based on results from the phase 2 SANS-UUI trial (NCT04232696), in which 84.2% of patients achieved at least a 50% reduction in urgent leaks.

8. FDA greenlights phase 1 trial of theranostic radiopharmaceutical for mCRPC

On June 20, 2025, Archeus Technologies announced FDA clearance of an investigational new drug application for ART-101, a novel PSMA-targeting radiopharmaceutical for mCRPC. With this clearance, the company plans to initiate a phase 1 trial of the agent later this year.

9. FDA expands Illuccix label to include patient selection for RLT in pre-taxane setting

On June 23, 2025, Telix Pharmaceuticals announced that the FDA approved a label expansion for Illuccix (kit for the preparation of gallium Ga-68 gozetotide) to include use in patient selection for PSMA-targeted radioligand therapy in patients with prostate cancer who have not yet received taxane-based chemotherapy. This update aligns with the March 2025 FDA approval of ¹⁷⁷Lu-PSMA-617 (Pluvicto) for earlier use in pre-taxane mCRPC.

10. FDA grants RMAT designation to detalimogene voraplasmid for high-risk NMIBC

On June 25, 2025, the FDA granted a Regenerative Medicine Advanced Therapy designation to detalimogene voraplasmid (formerly EG-70) for the treatment of patients with high-risk BCG-unresponsive NMIBC with carcinoma in situ. Detalimogene is an investigational, non-viral gene-based immunotherapy currently under evaluation in the pivotal phase 1/2 LEGEND trial. Preliminary data from the study showed an overall complete response rate of 71% in patients with BCG-unresponsive disease.

11. FDA grants breakthrough device designation to urine test for bladder cancer detection

On June 30, 2025, the FDA granted a breakthrough device designation to the TOBY Test, an artificial intelligence (AI)-powered urine test for the early detection of bladder cancer. The TOBY test works by analyzing the molecular signatures of volatile organic compounds in urine.