FDA updates in urology: February 2026

Welcome to Urology Times’® monthly FDA update! February’s regulatory news was characterized by updates in the men’s and women’s health space, in addition to a notable milestone in the development of an investigational agent for urothelial carcinoma. At the end of February, the field also saw 2 FDA submissions for belzutifan-based combinations in kidney cancer based on data presented at the 2026 American Society of Clinical Oncology Genitourinary Cancers Symposium in San Francisco, California.

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FDA News in Urology from February 2026

1. FDA approves sildenafil oral film for men with erectile dysfunction

On February 5, 2026, IBSA USA announced FDA approval of VYBRIQUE, a sildenafil oral film for the treatment of erectile dysfunction in men aged 18 and older.¹ This approval is based on results from a 12-week, phase 3 randomized trial (NCT05490680) in 475 adult men, in which the sildenafil oral film demonstrated statistically significant improvements in sexual function vs placebo. VYBRIQUE is a single-dose, orally dissolving film that can be taken with or without water. The film, which is designed for discreet administration, is expected to be commercially available in the US in March 2026.

2. FDA approves label changes for first batch of menopausal hormone therapy products

On February 12, 2026, the FDA approved labeling changes removing boxed warning language regarding cardiovascular disease, breast cancer, and probable dementia for select menopausal hormone replacement therapies (HRT).² This approval is based on a comprehensive review of the scientific literature, including randomized data demonstrating reduced all-cause mortality and fractures among women who initiate hormone therapy within 10 years of menopause onset. The action represents the first batch of revisions following the agency’s November 2025 decision to align HRT labeling with the current evidence.

3. FDA grants fast track designation to nectin-4 radioconjugate for urothelial carcinoma

On February 24, 2026, Aktis Oncology announced that the FDA granted fast track designation to AKY-1189 for adult patients with locally advanced or metastatic urothelial carcinoma whose disease has progressed on or after prior systemic therapies.³ AKY-1189 is designed to deliver actinium-225 to Nectin-4–expressing tumors. The agent is currently under investigation in the phase 1b NECTINIUM-2 trial (NCT07020117), which is expected to have preliminary dose-escalation results in the first quarter of 2027.

4. FDA grants priority review to adjuvant belzutifan plus pembrolizumab for ccRCC

On February 28, 2026, Merck announced that the FDA granted priority review to supplemental applications for belzutifan (Welireg) in combination with pembrolizumab (Keytruda) or pembrolizumab and berahyaluronidase alfa-pmph (KEYTRUDA QLEX) for the adjuvant treatment of adult patients with clear cell renal cell carcinoma at increased risk of recurrence following nephrectomy. The submissions are backed by results from the phase 3 LITESPARK-022 trial (NCT05239728), in which the addition of belzutifan to pembrolizumab significantly improved disease-free survival vs pembrolizumab alone (HR, 0.72; 95% CI, 0.59 to 0.87; P = .0003). The FDA has set a PDUFA target action date of June 19, 2026.

5. FDA accepts sNDA for belzutifan plus lenvatinib for advanced renal cell carcinoma

On February 28, 2026, Merck announced that the FDA accepted supplemental new drug applications for belzutifan (Welireg) plus lenvatinib (Lenvima) for the treatment of adult patients with advanced clear cell renal cell carcinoma following prior PD-1 or PD-L1 inhibitor therapy. The submissions are supported by results from the phase 3 LITESPARK-011 trial (NCT04586231), which demonstrated improved progression-free survival (HR,0.70; 95% CI, 0.59 to 0.84; P = .00007) and objective response rate (52.6% vs 39.6%) with belzutifan plus lenvatinib compared with cabozantinib. The FDA has set a PDUFA target action date of October 4, 2026.

REFERENCES

1. IBSA USA announces FDA approval of VYBRIQUE™, the first and only oral film to treat men with erectile dysfunction. News release. IBSA USA. February 5, 2026. Accessed March 2, 2026. https://www.businesswire.com/news/home/20260205186522/en/IBSA-USA-Announces-FDA-Approval-of-VYBRIQUE-the-First-and-Only-Oral-Film-to-Treat-Men-with-Erectile-Dysfunction

2. FDA approves labeling changes to menopausal hormone therapy products. News release. FDA. February 12, 2026. Accessed March 2, 2026. https://www.fda.gov/news-events/press-announcements/fda-approves-labeling-changes-menopausal-hormone-therapy-products

3. Aktis Oncology receives U.S. FDA fast track designation for AKY-1189, a nectin-4 miniprotein radioconjugate. News release. Aktis Oncology Inc. February 24, 2026. Accessed March 2, 2026. https://www.globenewswire.com/news-release/2026/02/24/3243465/0/en/Aktis-Oncology-Receives-U-S-FDA-Fast-Track-Designation-for-AKY-1189-a-Nectin-4-Miniprotein-Radioconjugate.html