Hannah Clarke

Enolen implants demonstrated minimal systemic drug exposure and early signals of tumor volume reduction in localized prostate cancer.

The NCCN has recognized NAI plus BCG as an option for BCG-unresponsive papillary NMIBC as FDA review continues.

The OPTIMUM randomized trial demonstrated that microultrasonography-guided biopsy is noninferior to MRI fusion-guided biopsy for detecting clinically significant prostate cancer, with a streamlined in-office workflow, a manageable learning curve, and substantially lower cost that may help address diagnostic access gaps worldwide.

64Cu-SAR-bisPSMA demonstrated higher lesion detection rates, improved diagnostic accuracy, and a substantial impact on clinical management.

A subgroup analysis of the POTOMAC trial showed that durvalumab plus BCG I+M had consistent safety and efficacy in older patients with BCG-naïve high-risk NMIBC.

Clearance of the non-permanent implant technology is backed by safety and efficacy results from the pivotal Expander-2 trial.

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.

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.

Results from the AMPLIFY trial are intended to support an FDA submission seeking approval of 64Cu-SAR-bisPSMA as a diagnostic imaging agent for BCR of prostate cancer.

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

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.

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

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.

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.

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.