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The target action date for the application is June 19, 2026.

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

"The CR rates in both arms are compelling, being higher than 50% with both strategies…BI-EFS rates in participants at week 18 CR assessment were comparable between arms and were higher than 80% in both arms," said Andrea Necchi, MD.

"Belzutifan plus lenvatinib addresses an unmet clinical need and represents a potential new treatment option for patients with RCC that progressed after PD 1 or-L1 therapy,” said Robert J. Motzer, MD.

“After 28 months’ follow-up, the combination of pembrolizumab and belzutifan resulted in a statistically significant and clinically meaningful improvement in disease-free survival over pembrolizumab single agent,” said Toni K. Choueiri, MD.

"Tokyo BCG is noninferior to TICE. This means that the BCG shortage could be mitigated with the Tokyo strain," said Robert Svatek, MD, MSCI.

“When we looked at ctDNA dynamics, patients who had baseline and postneoadjuvant ctDNA negativity had the best outcomes," said Pooja Ghatalia, MD.

“Neoadjuvant and adjuvant EV/pembro significantly improved event-free survival, overall survival, and path CR rate vs neoadjuvant gem/cis in patients with muscle-invasive bladder cancer who are eligible for cisplatin-based chemotherapy and radical cystectomy," said Matthew D. Galsky, MD.

“Biochemical responses were seen at all dose levels, with an overall PSA50 response of 62% and a PSA90 response of 40%," according to Fred Saad, CQ, MD, FRCS, FCAHS.

"Capivasertib in combination with abiraterone represents a potential first-in-class targeted treatment for patients with this now PTEN-defined metastatic APMN,” said Daniel J. George, MD.

"Enzalutamide plus radium-223 is an option in first-line treatment for mCRPC patients with bone metastases," said Enrique Gallardo, MD.

Median OS was 28 months (95% CI, 13-NR) in arm 1, 37 months (95% CI, 26-NR) in arm 2, and 68 months (95% CI, 38-NR) in arm 3.

PROSTOX Standard estimates the risk of late genitourinary toxicity following conventionally fractionated or moderately hypofractionated radiation therapy for localized prostate cancer.

AKY-1189 is currently under investigation in the phase 1b NECTINIUM-2 trial.

Take a look into the top data set to be presented at this year's ASCO GU Cancers Symposium in San Francisco, California.

Data showed that measurement of ctDNA and utDNA could identify patients who are most likely to remain cancer-free following systemic therapy.

The combination of enfortumab vedotin plus pembrolizumab extended event-free and overall survival in patients with MIBC who are ineligible for cisplatin-based chemotherapy.

In this episode, Amy Pearlman, MD, sits down with Alan J. Wein, MD, PhD (hon), FACS, to discuss how the field of urology has evolved and how clinicians can thoughtfully evolve alongside it.

Across 7 randomized trials, 177Lu-PSMA-617 significantly prolonged progression-free survival vs standard therapies, with no significant difference in adverse events.

The agent was granted conditional marketing authorization based on data from the phase 2/3 QUILT-3.032 trial.

Surgeons at Cleveland Clinic completed the first commericial procedure using the Hugo robot-assisted surgery system in the US.

64Cu-SAR-bisPSMA PET/CT identified a statistically significant greater number of prostate cancer lesions per patient compared with 68Ga-PSMA-11 PET/CT.

Despite early termination of the trial, its results provide scientific rationale for further investigation into targeting alternative AR domains in mHSPC.

In this episode, host Amy Pearlman, MD, sits down with Bruce R. Kava, MD, for a a discussion on his career path from oncologic surgery to sexual medicine, revision penile prosthetics, and cancer survivorship.

FDA lifts boxed warnings on 6 menopausal hormone therapies following a review of the evidence on risks and benefits.

A newly published meta-analysis found that adding metastasis-directed therapy to standard of care was associated with extended progression-free survival in oligometastatic prostate cancer, without adding significant safety risks.

Beyond clinical care, this episode highlights the evolving role of advanced practice providers in urology.

A major focus of the episode is reconstructive urology, particularly the unpredictable and long-term effects of pelvic radiation.