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Final results from a phase 1 study of Erda-iDRS provide proof-of-concept for sustained local delivery of erdafitinib into the bladder.

Data showed that the addition of PSMA-PET/CT reduced the need for prostate biopsy by nearly half without compromising the detection of clinically significant prostate cancer.

Katy Beckermann, MD, PhD, discusses how emerging data from the LITESPARK trials—particularly LITESPARK-011 and LITESPARK-022—may expand the role of belzutifan-based combinations across renal cell carcinoma treatment, while emphasizing the clinical significance of durable responses, careful toxicity management, and the need for longer-term survival data to guide practice.

"Emerging evidence indicates that molecular imaging may enable more accurate detection of primary RCC, improve surveillance for recurrence, and enhance identification of metastatic lesions compared with conventional imaging," write the authors.

Lutetium-177 rosopatamab tetraxetan demonstrated an acceptable safety and tolerability profile with no new safety signals in patients with PSMA-positive mCRPC.

Neal D. Shore, MD, FACS, shares key findings from a post hoc analysis of the EMBARK trial showing that sustained PSA responses are possible following only 9 months of treatment with enzalutamide plus leuprolide.

Robert J. Motzer, MD, discusses the scientific rationale for the LITESPARK-011 study, its design and key findings, and how this combination could potentially influence treatment strategies in renal cell carcinoma.

ImmunityBio has resubmitted an sBLA for the combination following an FDA request for updated efficacy data.

“Once we actually get a J code for a medication, it really solidifies the amount of reimbursement that's going to occur,” says Jonathan Rubenstein, MD.

NDV-01, a sustained-release intravesical combo, delivered durable 12‑month complete responses in high-risk NMIBC, particularly among patients with BCG-unresponsive disease.

According to Lantheus, Pylarify TruVu is formulated to improve product stability at higher radioactive concentrations, facilitating more efficient manufacturing and distribution.

Sadashiv Bhole, MBBS, MS (Surgery), MCh (Urology), DNB (Genito-Urinary Surgery), FMASI, offers an in-depth perspective on how robotic platforms are being adopted across India.

In this episode of The UroOnc Minute, host Adam B. Weiner, MD, speaks with Christian D. Fankhauser, MD, MPH, about the evolving role of biomarkers in testicular cancer.

A central theme is the widening gap between clinical work and health care policy.

FX-909, a first-in-class PPARγ inverse agonist, demonstrated manageable toxicity and preliminary antitumor activity in patients with advanced urothelial carcinoma.

At SUFU 2026, 24-month data from the TITAN 2 trial showed that the Altaviva ITNM system provided sustained reductions in urgency urinary incontinence episodes, durable quality-of-life improvements, and a favorable safety profile through 24 months.

ImmunityBio plans to submit a biologics license application to the FDA by Q4 of 2026.

The PDUFA target action date is set for October 4, 2026.

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.