FDA Updates in Urology: January 2025

Credit: US Food and Drug Administration

Welcome to Urology Times’ monthly US Food and Drug Administration (FDA) update! This month, key developments include advances in prostate cancer treatment, a new approach to bladder cancer therapy, and expanded indications for emerging urologic drugs. Plus, a novel testosterone assay is set to impact diagnostic testing.

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FDA News in Urology for January 2025

1. FDA clears chemiluminescence-based immunoassay for free testosterone

On January 10, 2025, Revvity, Inc. announced FDA 510(k) clearance for EUROIMMUN’s automated chemiluminescence-based immunoassay (ChLIA) test for the quantitative measurement of free testosterone in serum or plasma. Based on its ability to deliver results in 48 minutes and its use of highly specific monoclonal antibodies, the test provides diagnostic insights for conditions such as hypogonadism, impotence, and polycystic ovarian syndrome. This marks the first FDA-cleared test for direct free testosterone measurement and expands EUROIMMUN’s reproductive testing portfolio.

2. FDA accepts NDA for 3-month leuprolide mesylate formulation for advanced prostate cancer

On January 13, 2025, Foresee Pharmaceuticals announced the FDA's acceptance of a new drug application for a 3-month formulation of leuprolide mesylate (Camcevi; 21 mg) long-acting injectable for advanced prostate cancer. Based on data from a phase 3 trial showing 97.9% of patients achieved testosterone suppression to castrate levels, the application is supported by efficacy and safety findings comparable to the existing 6-month formulation. The FDA has set a PDUFA target action date of August 29, 2025.

3. New Drug Application initiated with FDA for TAR-200 for NMIBC

On January 15, 2025, Johnson & Johnson announced the initiation of a new drug application submission with the FDA for TAR-200 in BCG-unresponsive high-risk non–muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS). Based on data from cohort 2 of the phase 2b SunRISe-1 trial, TAR-200 demonstrated an 83.5% complete response rate and was generally well tolerated, with most adverse events being mild to moderate lower urinary tract symptoms. The application is being reviewed through the FDA’s Real-Time Oncology Review program, which facilitates early data evaluation.

4. Anktiva targets expanded indication in US and global approvals in EU and UK

On January 15, 2025, ImmunityBio announced plans to submit a supplemental biologics license application (sBLA) to the FDA in 2025 for nogapendekin alfa inbakicept-pmln (Anktiva) in BCG-unresponsive NMIBC with papillary disease. Based on data from cohort B of the QUILT-3.032 trial, Anktiva plus BCG demonstrated a median disease-free survival of 19.3 months and a low cystectomy rate of 7%. If approved, this expansion would provide a new treatment option for patients at risk of radical cystectomy.

5. FDA fast tracks 64Cu-SAR-bisPSMA for biochemically recurrent prostate cancer

On January 24, 2025, Clarity Pharmaceuticals announced that the FDA granted fast track designation to 64Cu-SAR-bisPSMA for PET imaging of PSMA-positive lesions in patients with biochemical recurrence of prostate cancer. Based on data from the phase 1/2 COBRA trial, the agent identified lesions in up to 80% of patients with negative or equivocal standard scans and led to treatment plan changes in 48% of cases. This designation supports the ongoing phase 3 AMPLIFY trial, which aims to further evaluate its diagnostic efficacy.