Hannah Clarke

A recap of the FDA submissions and regulatory decisions in urology from June 2026.

A roundup of the key stories on benign urologic conditions from the second quarter of 2026.

A roundup of the key stories across genitourinary cancers from the second quarter of 2026.

Interim results from the phase 2 CONVERGE-01 trial showed encouraging antitumor activity and a manageable safety profile with Ac-225 rosopatamab tetraxetan in mCRPC.

The tentative approval spans tablets in 40-mg, 80-mg, 120-mg, and 160-mg strengths.

The following FAQs highlight key recommendations and practical takeaways from the 2026 AUA/SUO Advanced Prostate Cancer Guideline.

The NCCN recommends that clinicians consider using ctDNA-MRD testing to stratify risk and guide the use of adjuvant immunotherapy in patients who have not previously received an immune checkpoint inhibitor.

This decision marks the first approval of a PD-1 inhibitor plus antibody-drug conjugate regimen in the EU.

Enzalutamide plus talazoparib showed promising clinical activity in high-volume mHSPC, although with a notable toxicity burden.

The agency is requesting a removal of the limitation of use for age-related hypogonadism as well as updated warnings related to prostate cancer risk and benign prostatic hyperplasia.

Data from the RAMPART trial showed that durvalumab monotherapy missed the DFS threshold in resected RCC, though the combination with tremelimumab showed significant benefit.

The prospective RELIEF study will evaluate the safety and preliminary efficacy of IRE delivered via the NanoKnife System for BPH-related symptoms.

The approval is supported by data from the phase 3 PIVOT-PO trial, in which tebipenem demonstrated noninferiority to imipenem-cilastatin.

Daniel J. George, MD, discusses the clinical significance of the FDA approval of capivasertib, practical considerations for PTEN testing and toxicity management, and the broader implications of precision medicine for patients with advanced prostate cancer.

Daniel Eun, MD, discusses the future of reconstructive urology, highlighting the promise of telesurgery and AI-driven surgical technologies while emphasizing the practical barriers that must be addressed for widespread adoption.

Patients who developed ototoxicity during cisplatin treatment experienced less worsening of pure-tone audiometry thresholds in ears treated with ACOU085 compared with placebo-treated ears.

The approval is supported by data from the phase 3 CAPItello-281 trial.

The application is supported by data from the phase 3 LITESPARK-022 trial.

Long-term data from the phase 2 TROG 15.03 FASTRACK II trial support the safety and efficacy of stereotactic ablative body radiotherapy for primary renal cell carcinoma.

The approval adds another commercially available source of the PSMA-targeted radiotracer.

The addition of aglatimagene and valacyclovir to radiotherapy with or without ADT significantly improved disease-free survival in patients with intermediate- to high-risk localized prostate cancer.

The pivotal trial is assessing the non-inferiority of the Separo Vessel Sealing System vs conventional mucosal cautery vasectomy.

A recap of the FDA submissions and regulatory decisions in urology from May 2026.

Titan Prime will be available in the US via a phased launch beginning in late 2026.

The phase 2 ARACOG trial noted a greater decline in objectively measured cognitive function over 24 weeks among patients who received enzalutamide vs darolutamide for advanced prostate cancer.

Data also showed that ctDNA positivity at baseline was associated with worse DFS outcomes.

The approval is supported by data from the phase 3 POTOMAC trial.

The application is supported by data from the phase 3 KEYNOTE-905/EV-303 trial.

Interim results from the pivotal Expander-2 showed sustained symptom improvement through 24 months with the Urocross Expander system for BPH.