What urologists can expect in Q2 of 2026

The first quarter of 2026 delivered a steady stream of regulatory milestones and practice-shaping data for urologists. Notable highlights included the FDA’s approval of an accelerated thawing method for nadofaragene firadenovec-vncg (Adstiladrin), as well as 510(k) clearances for the Urocross Expander System for benign prostatic hyperplasia (BPH)-related lower urinary tract symptoms (LUTS) and the Break Wave Lithotripsy device for kidney stones, reflecting continued innovation across both oncology and benign conditions. These developments were complemented by data presented at major forums such as the 2026 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium and the European Association of Urology Congress, where emerging evidence helped refine treatment paradigms across genitourinary malignancies.

As the field builds on this momentum, the second quarter of the year is poised to bring additional regulatory decisions that may further influence clinical practice. Several high-profile FDA actions are anticipated, including an upcoming Oncologic Drugs Advisory Committee meeting to discuss an agent for prostate cancer, as well as regulatory decisions spanning genitourinary malignancies and infectious disease. Together, these expected milestones highlight the continued pace of innovation across the urology landscape.

In parallel, the global urology and oncology communities will reconvene at 2 of the field’s most prominent scientific gatherings: the American Urological Association (AUA) Annual Meeting in Washington, DC, and the ASCO Annual Meeting in Chicago, Illinois. These meetings are expected to deliver late-breaking data and multidisciplinary insights across prostate, bladder, and kidney cancers, offering a forward-looking view of evolving standards of care.

Collectively, the regulatory and scientific milestones anticipated in Q2 2026 signal a dynamic period ahead for the field.

Regulatory Decisions

Drug: Capivasertib

Indication: PTEN-deficient metastatic hormone-sensitive prostate cancer

Summary: On April 30, 2026, the Oncologic Drugs Advisory Committee with convene to discuss the supplemental new drug application (sNDA) for capivasertib (Truqap) tablets in combination with abiraterone acetate (Zytiga) for the treatment of adult patients with metastatic hormone-sensitive prostate cancer (mHSPC) that is PTEN-deficient as detected by an FDA-approved test.¹ The sNDA is supported by results from the phase 3 CAPItello-281 trial (NCT04493853), which met its primary end point by demonstrating that adding capivasertib to abiraterone and androgen deprivation therapy (ADT) significantly improved radiographic progression-free survival (rPFS) in this patient population. The median rPFS was 33.2 months (95% CI, 25.8 to 44.2) in the capivasertib arm vs 25.7 months (95% CI, 22.0 to 29.9) in the placebo arm (HR: 0.81; 95% CI, 0.66 to 0.98; P = .034).²

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Drug: Tebipenem pivoxil HBr

Indication: cUTI

PDUFA: June 18, 2026

Summary: The FDA is set to make a decision on an NDA for tebipenem pivoxil hydrobromide (HBr) on or by June 18, 2026. The proposed indication for the oral carbapenem antibiotic is for the treatment of patients with complicated urinary tract infections (cUTI), including pyelonephritis. The application is backed by findings from the phase 3 PIVOT-PO trial (NCT06059846), which met its primary end point by showing that tebipenem HBr was noninferior to imipenem-cilastatin in regard to the overall response rate (composite of clinical cure plus microbiological eradication) at the test-of-cure visit in hospitalized adult patients with cUTI.³

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Drug: Belzutifan in combination with pembrolizumab (Keytruda or Keytruda Qlex)

Indication: Adjuvant treatment of certain patients with clear cell RCC following nephrectomy

PDUFA: June 19, 2026

Summary: Shortly thereafter, the agency is expected to have a decision regarding to 2 supplemental applications seeking approval of 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 (ccRCC) who are at an increased risk of recurrence following nephrectomy. The FDA granted priority review to these applications following data from the phase 3 LITESPARK-022 trial (NCT05239728), which were presented at the 2026 ASCO Genitourinary Cancers Symposium in San Francisco, California. Overall, the trial met its primary end point by showing that the addition of belzutifan to adjuvant pembrolizumab significantly improved disease-free survival (DFS) vs pembrolizumab alone (HR, 0.72; 95% CI, 0.59 to 0.87; P = .0003).^4,5

Conferences

Meeting: 2026 AUA Annual Meeting

Dates: May 15-18, 2026

Location: Washington, DC

Summary: The urology community will make their way to the nation’s capital for this year’s AUA Annual Meeting. Spanning 4 days in Washington, DC, this year’s annual meeting is expected to showcase the latest advances in urologic medicine through a comprehensive program of scientific sessions, educational courses, and late-breaking research spanning the full spectrum of the field.

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Meeting: 2026 ASCO Annual Meeting

Dates: May 29-June 2, 2026

Location: Chicago, IL

Summary: This year’s ASCO Annual Meeting, taking place in Chicago, Illinois from May 29 to June 2, 2026, is expected to bring together tens of thousands of global oncology professionals to share the latest advances in cancer research and clinical practice. Urologists can expect a wealth of new data across prostate, bladder, and kidney cancer.

REFERENCES

1. April 30, 2026: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement. US Food & Drug Administration. March 27, 2026. https://www.fda.gov/advisory-committees/advisory-committee-calendar/april-30-2026-meeting-oncologic-drugs-advisory-committee-meeting-announcement-04302026#event-information

2. Fizazi K, Clarke NW, De Santis M, et al. A phase III study of capivasertib (capi) + abiraterone (abi) vs placebo (pbo) + abi in patients (pts) with PTEN deficient de novo metastatic hormone-sensitive prostate cancer (mHSPC): CAPItello-281. Presented at: 2025 ESMO Congress; October 17-21, 2025; Berlin, Germany. Abstract 2383O

3. Spero announces NDA resubmission of tebipenem HBr by GSK to the FDA for the treatment of complicated urinary tract infections, including pyelonephritis. News release. Spero Therapeutics. December 19, 2025. Accessed March 27, 2026. https://s3.amazonaws.com/b2icontent.irpass.cc/2748/rl160626.pdf 

4. KEYTRUDA® (pembrolizumab) plus WELIREG® (belzutifan) given as adjuvant therapy reduced the risk of disease recurrence or death by 28% compared to KEYTRUDA monotherapy in certain patients with earlier-stage renal cell carcinoma (RCC). News release. Merck. February 28, 2026. Accessed March 27, 2026. https://www.merck.com/news/keytruda-pembrolizumab-plus-welireg-belzutifan-given-as-adjuvant-therapy-reduced-the-risk-of-disease-recurrence-or-death-by-28-compared-to-keytruda-monotherapy-in-certain-patients-with/

5. Choueiri TK, Motzer RJ, Karam JA, et al. Adjuvant pembrolizumab plus belzutifan versus pembrolizumab for clear cell renal cell carcinoma (ccRCC): The randomized phase 3 LITESPARK-022 study. Presented at: 2026 American Society of Clinical Oncology Genitourinary Cancers Symposium. February 26-28, 2026. San Francisco, California. Abstract LBA418. https://meetings.asco.org/meetings/2026-asco-genitourinary-cancers-symposium/334/16925?presentation=256660