FDA news recap in urology for Q2 2025

The specialty of urology, following an eventful first quarter, had a busy Q2 with a flurry of FDA approvals (and 1 notable non-approval) ranging from benign prostatic hyperplasia (BPH) to urge incontinence to bladder cancer and prostate cancer.

Q2 saw approvals in bladder cancer, prostate cancer, BPH, and more.

Q2 also saw both the American Urological Association (AUA) and American Society of Clinical Oncology hold their annual meetings, in Las Vegas, Nevada and Chicago, Illinois, respectively. Both gatherings contained a great deal of scientific advances spanning the specialty. The AUA Annual Meeting was also notable for its release of the new guideline on genitourinary syndrome of menopause in collaboration with the Society of Urodynamics, Female Pelvic Medicine, & Urogenital Reconstruction.¹

With Q2 behind us, here’s a look back at notable news between April and June.

FDA grants 510(k) clearance to Glean Urodynamics System

Date: April 2, 2025

Indication: Adult patients with lower urinary tract dysfunction

Company: Bright Uro

Summary: The FDA has granted 510(k) clearance to the Glean Urodynamics System for adult patients with lower urinary tract dysfunction (LUTD), Bright Uro announced in a news release.² According to the company, the system is a “urodynamic analyzer system that is intended to quantify the pressure and flow characteristics of the lower urinary tract.” The device enables wireless, catheter-free ambulatory urodynamics monitoring that can aid decision-making for LUTD.

FDA clears stapler for use with da Vinci SP surgical system

Date: April 10, 2025

Company: Intuitive Surgical

Summary:T FDA granted 510(k) clearance to the SureForm 45 stapler for use with the da Vinci SP surgical system in urologic, thoracic, and colorectal procedures, Intuitive Surgical announced in a news release.¹ This approval marks the first clearance of a stapler designed for single-port robotic surgery in the US. According to the company, the fully-wristed stapler continuously monitors tissue compression before and during firing through the use of SmartFire technology. This technology is also utilized in the staplers for multiport procedures.

FDA approves darolutamide in metastatic castration-sensitive prostate cancer

Date: June 3, 2025

Indication: Metastatic castration-sensitive prostate cancer

Company: Bayer

Summary: The FDA has approved darolutamide (Nubeqa) for the treatment of adult patients with metastatic castration-sensitive prostate cancer (mCSPC), the agency announced in a news release.³ With this approval, darolutamide becomes the first androgen receptor inhibitor approved for use in patients with mCSPC with or without chemotherapy.

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

Date: June 11, 2025

Company: Boston Scientific

Indication: Treatment of patients with BPH with prostates up to 150 cm³ in size

Summary: The FDA has granted 510(k) clearance to a label expansion for the Rezūm System, raising the maximum prostate volume that can be treated with the device from 80 cm³ to 150 cm³ for patients with benign prostatic hyperplasia (BPH).^4,5

Related: Kevin T. McVary, MD, FACS, discusses the expanded label for Rezum in BPH

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

Date: June 12, 2025

Company: UroGen Pharma

Indication: Recurrent low-grade intermediate-risk non–muscle invasive bladder cancer

Summary: The FDA approved 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, the agency announced in a news release.⁶ This approval marks the first FDA-approved medication in this disease setting. Mitomycin for intravesical solution is expected be available in the US on or around July 1, 2025, UroGen reported.⁷ According to the FDA, the recommended dose for the therapy is 75 mg (56 mL) instilled once weekly for 6 weeks into the bladder via a urinary catheter.

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

Date: June 13, 2025

Indication: Broader use in the treatment of patients with non-HRR gene mutated metastatic castration-resistant prostate cancer

Company: Pfizer

Summary: The FDA declined to approve expanded labeling for the combination of talazoparib (Talzenna) plus enzalutamide (Xtandi) to include broader use in the treatment of patients with non-HRR gene mutated metastatic castration-resistant prostate cancer (mCRPC), Pfizer announced in a news release.⁸ The combination of talazoparib plus enzalutamide is currently approved for the treatment of patients with HRR-gene mutated mCRPC as of an FDA decision in June 2023.⁹

FDA approves integrated sacral neuromodulation system for urinary urge incontinence

Date: June 18, 2025

Indication: Urinary urge incontinence

Company: Neuspera Medical

Summary: The FDA has granted clearance to Neuspera Medical’s integrated sacral neuromodulation (iSNM) system for the treatment of patients with urinary urge incontinence (UUI), the company announced in a news release.¹⁰ The iSNM system is intended to provide an alternative to traditional SNM for these patients. According to Neuspera, “A smart, miniaturized neurostimulator is implanted near the sacral nerve, and therapy is activated using an external disc worn against the lower back for approximately 2 hours daily. When not in use, the therapy disc charges wirelessly, like a smartphone.”

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

Date: June 23, 2025

Indication: Patient selection for prostate-specific membrane antigen-targeted radioligand therapy in patients with prostate cancer who have not received prior taxane-based chemotherapy

Company: Telix Pharmaceuticals

Summary: The FDA has approved a label expansion for Illuccix (kit for the preparation of gallium Ga-68 gozetotide, for injection) to include use in patient selection for prostate-specific membrane antigen (PSMA)-targeted radioligand therapy (RLT) in patients with prostate cancer who have not received prior taxane-based chemotherapy.¹¹ Illuccix, after radiolabeling with Ga 68, is approved in the US for PET imaging of PSMA-positive lesions in patients with prostate cancer:

• With suspected metastasis who are candidates for initial definitive therapy,

• With suspected recurrence based on elevated prostate-specific antigen level,

• And for the selection of patients who are indicated for PSMA-directed RLT therapy

According to Telix Pharmaceuticals, “The update applies to Illuccix’s third indication, for selection of patients who are indicated for PSMA-directed therapy as described in the Prescribing Information of the therapeutic products.”

REFERENCES

1. Kaufman MR, Ackerman LA, Amin KA, et al. The AUA/SUFU/AUGS Guideline on Genitourinary Syndrome of Menopause. J Urol. 2025 Apr 29:101097JU0000000000004589. doi:10.1097/JU.0000000000004589

2. Bright Uro receives FDA clearance for Glean Urodynamics System. News release. Bright Uro. April 2, 2025. Accessed April 2, 2025. https://www.businesswire.com/news/home/20250402777960/en/Bright-Uro-Receives-FDA-Clearance-for-Glean-Urodynamics-System

3. FDA approves darolutamide for metastatic castration-sensitive prostate cancer. News release. US Food & Drug Administration. Published online and accessed June 3, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-darolutamide-metastatic-castration-sensitive-prostate-cancer

4. Section 510(k) premarket notification for Rezum System. FDA. June 11, 2025. Accessed June 20, 2025. https://bostonscientific.showpad.com/share/fhLW6RP6GHlhhVecgQsXX

5. 510(k) premarket notification database. FDA. Accessed June 20, 2025. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250584

6. FDA approves mitomycin intravesical solution for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer. News release. US Food & Drug Administration. Published online and accessed June 12, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mitomycin-intravesical-solution-recurrent-low-grade-intermediate-risk-non-muscle

7. U.S. FDA approves UroGen’s ZUSDURI (mitomycin) for intravesical solution as the first and only medication for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). News release. UroGen. Published online and accessed June 12, 2025. https://investors.urogen.com/news-releases/news-release-details/us-fda-approves-urogens-zusduritm-mitomycin-intravesical

8. Pfizer provides update on U.S. regulatory review of TALZENNA in combination with XTANDI for broader use in metastatic castration-resistant prostate cancer. News release. Pfizer. June 13, 2025. Accessed June 17, 2025. https://www.pfizer.com/news/announcements/pfizer-provides-update-us-regulatory-review-talzenna-combination-xtandi-broader

9. FDA approves talazoparib with enzalutamide for HRR gene-mutated metastatic castration-resistant prostate cancer. News release. US Food & Drug Administration. June 20, 2023. Accessed June 17, 2025. https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-talazoparib-enzalutamide-hrr-gene-mutated-metastatic-castration-resistant-prostate

10. Neuspera Medical receives FDA approval for first integrated sacral neuromodulation (iSNM) system for urinary urge incontinence. News release. Neuspera Medical. Published online and accessed June 18, 2025. https://www.prnewswire.com/news-releases/neuspera-medical-receives-fda-approval-for-first-integrated-sacral-neuromodulation-isnm-system-for-urinary-urge-incontinence-302484795.html

11. Illuccix approved in U.S. for patient selection for pre-taxane RLT. News release. Telix Pharmaceuticals. Published online and accessed June 23, 2025. https://telixpharma.com/news-views/illuccix-approved-in-u-s-for-patient-selection-for-pre-taxane-rlt/