FDA updates in urology: July 2025

Welcome to Urology Times’® monthly FDA update! In July, notable advancements were made in the development of a combination regimen for metastatic prostate cancer, an emerging agent in non–muscle invasive bladder cancer (NMIBC), a medication for hypoactive sexual desire disorder (HSDD), and more.

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FDA News in Urology for July 2025

1. FDA and EMA authorize phase 3 trial of masitinib for mCRPC

On July 4, 2025, AB Science announced FDA and European Medicines Agency authorization for a confirmatory phase 3 trial of masitinib in combination with docetaxel in patients with metastatic castration-resistant prostate cancer (mCRPC). Masitinib was explored in a prior phase 3 study in mCRPC, showing that masitinib plus docetaxel significantly improved progression-free survival in patients with lower baseline alkaline phosphatase levels (250 IU/L or lower).

2. FDA grants fast track designation to TRE-515 with 177Lu-PSMA-617 for mCRPC

On July 9, 2025, Trethera Corporation announced that the FDA granted fast track designation to TRE-515 in combination with ¹⁷⁷Lu-PSMA-617 (Pluvicto) for the treatment of patients with mCRPC. The designation was granted in part based on phase 1 trial results showing early evidence of antitumor activity as well as a favorable safety profile in patients with advanced solid tumors.

3. FDA grants priority review to NDA for TAR-200 in BCG-unresponsive NMIBC

On July 17, 2025, Johnson & Johnson announced FDA priority review of its new drug application (NDA) for TAR-200 in patients with BCG-unresponsive high-risk NMIBC with carcinoma in situ with or without papillary tumors. The NDA is primarily supported by data from cohort 2 of the phase 2b SunRISe-1 trial (NCT04640623), which showed an 82.4% complete response rate with favorable tolerability. Full results from the SunRISe-1 trial were recently published in the Journal of Clinical Oncology.

4. FDA, French ANSM greenlight pivotal trial of UroActive smart implant for male SUI

On July 17, 2025, UroMems announced FDA and French National Agency for the Safety of Medicines and Health Products clearance for a pivotal trial of the UroActive smart implant in men with stress urinary incontinence (SUI). The trial, called SOPHIA2 (NCT06968741), plans to enroll approximately 140 male patients with SUI across clinical trial sites in the US and France.

5. FDA clears image-guided navigation platform for focal therapy in prostate cancer

On July 23, 2025, Philips announced FDA 510(k) clearance for an updated version of its UroNav System for use in focal therapy procedures for prostate cancer. The technology is designed to integrate pre-procedural imaging with real-time ultrasound and includes an advanced annotation workflow to support precision focal therapy planning and delivery.

6. FDA grants priority review to expanded indication of flibanserin in HSDD

On July 24, 2025, Sprout Pharmaceuticals announced FDA priority review of a supplemental application seeking an expanded indication of flibanserin (Addyi) to treat hypoactive sexual desire disorder (HSDD) in postmenopausal women. Safety and efficacy data from the SNOWDROP and PLUMERIA trials are supporting expanded use of the non-hormonal treatment beyond its original 2015 approval for premenopausal women.