FDA updates in urology: April 2026

Welcome to Urology Times’® monthly FDA update! This month’s regulatory activity features several potentially practice-changing developments across the field, including early movement toward a possible testosterone therapy label expansion, high-impact regulatory progress in perioperative bladder cancer therapy, and FDA advisory committee support for capivasertib (Truqap) in PTEN-deficient metastatic hormone-sensitive prostate cancer (mHSPC). Notably, the FDA’s signals around testosterone replacement therapy could meaningfully reshape care in men’s health, while priority review of enfortumab vedotin-ejfv (Padcev) plus pembrolizumab (Keytruda) in muscle-invasive bladder cancer (MIBC) has the potential to redefine the standard of care if approved.

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FDA news in urology from April 2026

1. FDA grants Breakthrough Device Designation to urine-based multi-cancer early detection test

On April 14, 2026, TOBY announced FDA Breakthrough Device Designation for its urine-based multi-cancer early detection test that includes detection for prostate, bladder, and kidney cancer.¹ The test analyzes volatile organic compounds in urine using spectroscopy and machine learning to identify cancer-associated molecular patterns, offering a potential alternative to blood-based screening approaches.

2. FDA signals potential pathway for testosterone therapy label expansion

On April 16, 2026, the FDA opened the door to potentially expanding the label for testosterone replacement therapy to include use in men with low libido associated with idiopathic hypogonadism. The agency encouraged sponsors of approved testosterone products to contact the agency to engage in discussions regarding potential supplemental new drug applications for this indication. The agency emphasized that any label change would require robust data demonstrating a favorable benefit-risk profile.²

3. FDA grants priority review to EV plus pembrolizumab for cisplatin-eligible MIBC

On April 20, 2026, Merck announced FDA priority review for supplemental biologics license applications for pembrolizumab and pembrolizumab and berahyaluronidase alfa-pmph (KEYTRUDA QLEX), each in combination with enfortumab vedotin as perioperative regimens for patients with cisplatin-eligible MIBC.³ The applications are based on data from the phase 3 KEYNOTE-B15/EV-304 trial (NCT04700124), in which the perioperative regimen showed significant improvements in event-free survival, overall survival, and pathologic complete response compared with neoadjuvant gemcitabine/cisplatin. The FDA assigned a PDUFA target action date of August 17, 2026, with findings suggesting the potential to redefine the standard of care in this setting.

4. FDA ODAC votes in favor of capivasertib plus abiraterone in PTEN-deficient mHSPC

On April 30, 2026, the FDA Oncologic Drugs Advisory Committee (ODAC) voted 7 to 1 with 1 abstention in support of a favorable benefit-risk profile for capivasertib in combination with abiraterone (Zytiga) and prednisone for patients with PTEN-deficient mHSPC.⁴ The recommendation is based on data from the phase 3 CAPItello-281 trial (NCT04493853) demonstrating a statistically significant improvement in radiographic progression-free survival compared with abiraterone plus placebo (HR, 0.81), along with manageable but increased toxicity including diarrhea, hyperglycemia, and rash. The committee noted the modest magnitude of benefit and lack of mature overall survival data, but supported a biomarker-selected indication pending FDA review of the sNDA.

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