Credit: US Food and Drug Administration
Welcome to the monthly FDA update from Urology Times! This issue highlights significant progress in the field of urology, featuring advancements in prostate cancer treatment, innovative therapies for bladder cancer, and exciting expansions for existing urologic medications. Additionally, a sophisticated new assay for testosterone measurement is poised to transform diagnostic testing.
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FDA News in Urology for January 2025
1. FDA Approves New Free Testosterone Immunoassay
On January 10, 2025, Revvity, Inc. received FDA 510(k) clearance for EUROIMMUN’s automated chemiluminescence-based immunoassay (ChLIA) test for measuring free testosterone levels in blood. With a rapid turnaround of 48 minutes and highly specific monoclonal antibodies, this test offers precise diagnostic tools for conditions like hypogonadism, erectile dysfunction, and polycystic ovarian syndrome. It represents the first FDA-cleared method for direct free testosterone measurement and enhances EUROIMMUN’s reproductive health testing lineup.
2. FDA Accepts NDA for Three-Month Leuprolide Mesylate for Prostate Cancer
On January 13, 2025, Foresee Pharmaceuticals informed the FDA of its acceptance for an NDA related to a three-month formulation of leuprolide mesylate (Camcevi; 21 mg), a long-acting injectable used for advanced prostate cancer. Derived from a phase 3 trial where 97.9% of patients achieved castrate testosterone levels, the application is backed by robust efficacy and safety data. The FDA has set an action date of August 29, 2025, for reviewing the submission.
3. FDA Review Begins for TAR-200 in Bladder Cancer
On January 15, 2025, Johnson & Johnson initiated a new drug application for TAR-200 in treating BCG-unresponsive high-risk non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS). Phase 2b trial data from cohort 2 showed an 83.5% complete response rate, with mild to moderate side effects primarily affecting the urinary tract. The FDA is reviewing the application through its Real-Time Oncology Review program to expedite data analysis.
4. Anktiva Seeks Expanded Indication in US and Global Approvals
On January 15, 2025, ImmunityBio announced plans to submit a supplemental biologics license application (sBLA) for nogapendekin alfa-inbakicept-pmln (Anktiva) to treat BCG-unresponsive NMIBC with papillary disease in the US. Based on cohort B data from the QUILT-3.032 trial, Anktiva combined with BCG achieved a median disease-free survival of 19.3 months and a low risk of cystectomy at 7%. This potential approval could introduce a new therapeutic option for patients at high risk for radical surgery.
5. 64Cu-SAR-bisPSMA Receives FDA Fast Track Designation
On January 24, 2025, Clarity Pharmaceuticals announced the FDA’s fast track designation for 64Cu-SAR-bisPSMA, a molecule used for PET imaging of PSMA-positive lesions in patients with biochemically recurrent prostate cancer. The phase 1/2 COBRA trial demonstrated its ability to detect lesions in up to 80% of patients with inconclusive standard scans, influencing 48% of treatment plans. This designation supports further investigation in the phase 3 AMPLIFY trial to validate its diagnostic accuracy.
The FDA approvals and designations discussed in this update reflect ongoing progress in advancing urologic care, incorporating innovative treatments and accurate diagnostics to improve patient outcomes.
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