FDA updates in urology: May 2025

Welcome to Urology Times’® monthly FDA update! In May, key developments included 2 FDA Advisory Committee meetings on upcoming regulatory decisions, movement of a point-of-care men’s sexual health test into FDA review, and advancement of CAN-2409 along its regulatory pathway for localized prostate cancer.

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Last month held notable developments in bladder cancer, prostate cancer, and men's health.

FDA news in urology for May 2025

1. FDA issues refusal to file letter on sBLA for nogapendekin alfa inbakicept

On May 2, 2025, ImmunityBio announced the FDA issued a Refusal to File (RTF) letter for its supplemental biologics license application (sBLA) seeking approval of nogapendekin alfa inbakicept-pmln (NAI; Anktiva) plus BCG for BCG-unresponsive non–muscle invasive bladder cancer (NMIBC) in the papillary-only indication.¹ According to ImmunityBio, the RTF letter came after receiving unanimous guidance from leadership at the agency to submit the sBLA during an in-person meeting in January. NAI was previously approved by the FDA in April 2024 for use in combination with BCG for patients with BCG-unresponsive NMIBC with carcinoma in situ with or without papillary disease.

2. FDA Advisory Committee finds evidence for UGN-102 inconclusive, cites uncertainty in benefit-risk

On May 21, 2025, the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 4-5 in opposition of a favorable benefit-risk profile for UGN-102 (mitomycin) intravesical solution in adult patients with recurrent low-grade intermediate-risk non–muscle invasive bladder cancer (LG-IR-NMIBC).² The ODAC meeting was called to discuss whether durable complete response in a single-arm trial was sufficient to ascertain efficacy in LG-IR-NMIBC, and whether the overall benefit-risk for UGN-102 was favorable. The FDA is set to have a decision on the new drug application for UGN-102 on or by June 13, 2025.

3. FDA Advisory Committee unanimously votes against talazoparib plus enzalutamide for mCRPC

The FDA’s ODAC voted in a unanimous 0-8 decision that the TALAPRO-2 data on talazoparib (Talzenna) plus enzalutamide (Xtandi) is not sufficient to conclude a favorable benefit-risk profile for the combination in adult patients with metastatic castration-resistant prostate cancer (mCRPC) unselected for homologous recombination repair (HRR) gene alterations.² In their decision, the committee expressed concerns over a trial design that did not specifically stratify for patients without HRR gene mutations, as well as concerns over the toxicity of the regimen in this population. The FDA previously approved talazoparib in combination with enzalutamide for patients with HRR-positive mCRPC in June 2023, based on data from TALAPRO-2.

4. Application submitted to FDA for 510(k) clearance of Men’s Sexual Health Test

On May 27, 2025, Visby Medical announced that they had submitted a 510(k) application and CLIA waiver request to the FDA for their point-of-care Men’s Sexual Health Test for chlamydia and gonorrhea.³ The single-use test is designed to deliver results from male urine samples in about 30 minutes, with no need for refrigeration or capital equipment.

5. FDA awards Regenerative Medicine Advanced Therapy Designation to CAN-2409 for prostate cancer

On May 28, 2025, Candel Therapeutics announced that the FDA granted a Regenerative Medicine Advanced Therapy (RMAT) designation to aglatimagene besadenovec (CAN-2409) for newly diagnosed intermediate- to high-risk localized prostate cancer.⁴ The efficacy of CAN-2409 was established in the phase 3 PrTK03 trial (NCT01436968), which found that the addition of CAN-2409 to radiation therapy significantly improved disease-free survival vs radiation alone in patients with localized prostate cancer. The company plans to submit a biologics license application to the FDA at the end of 2026.

REFERENCES

1. ImmunityBio requests an urgent meeting with FDA to address the change in the Agency’s unambiguous guidance on Jan 2025 to submit a sBLA for NMIBC BCG unresponsive papillary disease, following an inconsistent refusal to file letter on May 2, 2025. News release. ImmunityBio. May 5, 2025. Accessed June 2, 2025. https://www.businesswire.com/news/home/20250505409104/en/ImmunityBio-Requests-an-Urgent-Meeting-With-FDA-to-Address-the-Change-in-the-Agencys-Unambiguous-Guidance-on-Jan-2025-to-Submit-a-sBLA-for-NMIBC-BCG-Unresponsive-Papillary-Disease-Following-an-Inconsistent-Refusal-to-File-Letter-on-May-2-2025

2. May 20-21, 2025 Meeting of the Oncologic Drugs Advisory Committee. US Food & Drug Administration. Accessed June 2, 2025. https://www.fda.gov/advisory-committees/advisory-committee-calendar/may-20-21-2025-meeting-oncologic-drugs-advisory-committee-05202025

3. Visby Medical submits Men's Sexual Health Test to FDA for clearance and CLIA waiver. News release. Visby Medical. May 27, 2025. Accessed June 2, 2025. https://www.prnewswire.com/news-releases/visby-medical-submits-mens-sexual-health-test-to-fda-for-clearance-and-clia-waiver-302465364.html

4. Candel Therapeutics receives FDA Regenerative Medicine Advanced Therapy Designation for CAN-2409 for the treatment of prostate cancer. News release. Candel Therapeutics. May 28, 2025. Accessed June 2, 2025. https://ir.candeltx.com/news-releases/news-release-details/candel-therapeutics-receives-fda-regenerative-medicine-advanced