"It is important as a field that we recognize the potential emotional impact of surgical adverse events," writes Amy N. Luckenbaugh, MD.

Following the positive recommendation, the European Commission will now review the application for vibegron for potential approval in the OAB setting in all EU member states, as well as in Iceland, Liechtenstein, and Norway.

"There are opportunities for doctors to become more productive, to see more patients, and to avoid the erosion of their incomes," writes Neil Baum, MD.

"I think in terms of the 2 large tool sets we have, biomarker testing through urine or blood tests and imaging. I think both are only going to get better," says Jeffrey Tosoian, MD, MPH.

Petros also announced that it has received positive feedback from the FDA after the agency’s informal review of Petros’ technology component for self-selection.

The clearance of the IND application for RAG-01 will initiate the launch of clinical trials in the US.

A decision regarding EU marketing authorization is expected by June 2024.

“ARO-HIF2’s ability to target cancer cells, disrupting a key tumor-driving mechanism, illustrates the potential of siRNA technology in oncology,” says James Brugarolas, MD, PhD.

Dean S. Elterman, MD, MSc, FRCSC, highlights several studies in BPH being presented at the 2024 AUA Annual Meeting.

"And [3 out of 5] of those patients who were initially deemed to go on to nephroureterectomy were able to be converted to endoscopic management," says Surena F. Matin, MD.

“This brand new guideline offers options for all patients with OAB with a focus on shared decision-making between patients with OAB and clinicians, as well as a personalized, tailored approach to care,” said Cameron and Smith.

The approval is based on 3 clinical trials evaluating the efficacy of different pivmecillinam dosing regimens in comparison with either placebo, another oral antibacterial drug, or ibuprofen.

Adam B. Weiner, MD, highlights several studies in prostate cancer set to be presented at the upcoming 2024 American Urological Association Annual Meeting.

The approval is supported by data from the phase 3 EMBARK trial, which demonstrated that enzalutamide with or without leuprolide prolonged metastasis-free survival compared with leuprolide alone in patients with high-risk biochemically recurrent nmHSPC.

Both the SOLAR-STAGE and SOLAR-RECUR trials are currently enrolling patients with prostate cancer in the US, with additional sites expected to open in Europe later this year.

Karine Tawagi, MD, highlights several studies in bladder cancer being presented at the 2024 American Urological Association Annual Meeting.

Findings from the study showed a clinical response rate of 76.4% and 78.4% at 6- and 12-months following activation of the device among patients in the intent-to-treat population.

"To answer this question, one must know what is and is not included in the global payment for the UDS, and the definition and instructions for appropriate use of modifier 25," write Jonathan Rubenstein, MD, and Mark Painter.

The approval is supported by findings of the ongoing QUILT-3.032 trial, assessing nogapendekin alfa inbakicept (N-803) plus BCG in patients with BCG-unresponsive non–muscle-invasive bladder cancer.

"At a time when patients are increasingly concerned about prescription drugs, this information will provide a useful starting point for making essential medications as affordable as possible," says Ruchika Talwar, MD.

"This preplanned ENACT trial biomarker analysis demonstrates the value of the Decipher score, AR-A score, and PAM50 genomic classifiers in identifying patients undergoing AS who are most likely to benefit from enzalutamide treatment," wrote the authors.

"The advance of PSMA imaging has put an emphasis on multidisciplinary care," says Kenneth J. Pienta, MD.

"We look forward to announcing initial efficacy and safety data from the study, which we expect will be at the end of this quarter," says Salim Yazji, MD.

“This is the first study to show a statistically significant and clinically meaningful survival improvement with any adjuvant therapy in kidney cancer, and this further supports adjuvant pembrolizumab as a standard of care after surgery in this disease setting,” says Toni K. Choueiri, MD.

The MPS2 models demonstrated negative predictive values of 95% to 99% for cancers of grade group 2 or higher and of 99% for cancers of grade group 3 or higher.