FDA updates in urology: February 2025

Welcome to Urology Times’® monthly FDA update! This month, key developments include advances in prostate and kidney cancer detection, as well as an emerging treatment option in primary hyperoxaluria 1 (PH1).

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FDA News in Urology for February 2025

1. FDA awards orphan drug, rare pediatric disease designations to ABO-101 for PH1

On February 5, 2025, Arbor Biotechnologies announced that the FDA granted orphan drug and rare pediatric disease designations to the investigational gene editing therapy ABO-101 for the treatment of patients with primary hyperoxaluria type 1 (PH1). Preclinical studies showed ABO-101’s ability to target the HAO1 gene, reduce oxalate production, and preserve genomic integrity in non-human primates. The company plans to initiate the phase 1/2 redePHine trial in the first half of 2025 to evaluate the therapy’s safety and efficacy in patients with PH1.

2. FDA grants 510(k) clearance to AI-powered prostate cancer diagnostic

On February 10, 2025, Ibex Medical Analytics announced FDA 510(k) clearance for Ibex Prostate Detect, an AI-powered digital pathology software for detecting prostate cancer in tissue biopsies. This decision was based on validation studies showing a 99.6% positive predictive value for heatmap accuracy, as well as data showing that pathologists diagnosing without AI missed 13% of the cancer cases that were identified by the AI. This marks Ibex’s first FDA clearance, and the company is hoping that the clearance will bolster adoption of AI-powered digital pathology in clinical practice.

3. FDA grants fast track designation to ⁶⁷Cu-SAR-bisPSMA for mCRPC

On February 19, 2025, Clarity Pharmaceuticals announced that the FDA granted fast track designation to ⁶⁷Cu-SAR-bisPSMA for the treatment of patients with PSMA-positive metastatic castration-resistant prostate cancer who were previously treated with an androgen receptor pathway inhibitor. This designation is supported by preliminary data from the ongoing phase 1/2a SECuRE trial (NCT04868604), which has shown promising prostate-specific antigen reductions and manageable safety in heavily pretreated patients. The designation enables Clarity to expedite development, with the trial now evaluating multi-dose regimens and potential combination therapy with enzalutamide.

4. FDA grants priority review to ⁸⁹Zr-DFO-girentuximab for kidney cancer imaging

On February 25, 2025, Telix Pharmaceuticals announced that the FDA accepted and granted priority review to a biologics license application (BLA) for ⁸⁹Zr-DFO-girentuximab (Zircaix) for PET imaging of clear cell renal cell carcinoma (ccRCC). The BLA is backed by data from the phase 3 ZIRCON trial, which demonstrated high sensitivity (85.5%) and specificity (87%) in detecting ccRCC in patients with an indeterminate renal mass. The FDA has set a PDUFA target action date of August 27, 2025 for the application.