FDA updates in urology: August 2025

Welcome to Urology Times’® monthly FDA update! August ushered in several notable advancements, with a particular focus in prostate cancer. Specifically, key developments included regulatory approval of an artificial intelligence (AI)-based test, acceptance of an application for a new formulation of a prostate-specific membrane antigen (PSMA)-PET imaging agent, and approval of a new formulation of a drug for advanced prostate cancer.

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FDA News in Urology for August 2025

1. FDA accepts NDA for new formulation of piflufolastat F 18 in prostate cancer

On August 6, 2025, Lantheus announced that the FDA had accepted a new drug application seeking approval of a new formulation of their PSMA-PET imaging agent, piflufolastat F 18 (Pylarify; 18F-DCFPyL) in prostate cancer. The agency is set to make a decision on the application either on or by March 6, 2026.

According to Lantheus, the new formulation of the imaging agent is expected to increase batch size by around 50%.

2. FDA grants priority review to gepotidacin for uncomplicated urogenital gonorrhea

On August 11, 2025, the FDA granted priority review to a supplemental new drug application (sNDA) seeking approval of gepotidacin as an oral treatment for uncomplicated urogenital gonorrhea in patients 12 years of age and older (weighing ≥45 kg). The target action date for the application is December 11, 2025.

The sNDA is supported by data from the phase 3 EAGLE-1 trial (NCT04010539), which showed that gepotidacin was non-inferior to combined treatment with intramuscular ceftriaxone plus oral azithromycin in regard to the treatment success rates (microbiological response) at the urogenital site.

3. FDA grants de novo authorization to ArteraAI Prostate

On August 13, 2025, Artera announced that the FDA granted de novo authorization to ArteraAI Prostate, the first AI-powered risk stratification tool for patients with non-metastatic prostate cancer. The approval was based on validation across multiple phase 3 trials, where the multimodal AI platform demonstrated superiority over standard risk models and identified patients most likely to benefit from therapies such as short-term hormone therapy or androgen receptor pathway inhibitors.

4. FDA grants fast track designation to HLD-0915 in mCRPC

On August 14, 2025, Halda Therapeutics announced that the FDA granted fast track designation to HLD-0915 for the treatment of patients with metastatic castration-resistant prostate cancer.

Preclinical data showed that the investigational bifunctional small molecule therapy led to tumor shrinkage, declines in prostate-specific antigen levels, and activity in models of drug resistance. The agent is being further evaluated in an ongoing phase 1/2 trial (NCT06800313).

5. FDA issues complete response letter for 89Zr-DFO-girentuximab in ccRCC

On August 28, 2025, Telix announced that the FDA issued a complete response letter (CRL) on their biologics license application (BLA) for ⁸⁹Zr-DFO-girentuximab (Zircaix; TLX250-CDx), an investigational agent for PET imaging of clear cell renal cell carcinoma (ccRCC).

The CRL cited deficiencies related to the Chemistry, Manufacturing, and Controls package and requested additional data “to establish comparability between the drug product used in the ZIRCON phase 3 clinical trial and the scaled-up manufacturing process intended for commercial use.” Telix reported that they planned to schedule a Type A meeting with the FDA to develop a plan to address these concerns and determine an appropriate timeline for resubmission.

6. FDA approves 3-month formulation of leuprolide mesylate for advanced prostate cancer

On August 28, 2025, Foresee Pharmaceuticals announced that the FDA had approved a 3-month formulation of leuprolide mesylate (Camcevi ETM; 21 mg) long-acting injectable (LAI) for adult patients with advanced prostate cancer. A 6-month formulation of leuprolide (50 mg) was previously approved by the FDA in May 2021.

The approval of the 21 mg formulation was supported by findings from an open-label, single-arm, phase 3 trial, which met its primary end point with 97.9% of patients achieving a serum testosterone concentration suppression to castrate levels (≤ 50 ng/dL) by day 28 and from day 28 through day 168.