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.

"There are plenty of articles written about stress-induced urgency. I, at the time, only found 1 article written in the gynecologic literature about what they called stand-up urgency," according to Colin Goudelocke, MD.

“We are hopeful that this therapy will help patients with prostate cancer and that this study will be just the first step towards the effective treatment of other bone tumors,” said Daniel Abate-Daga, PhD.

“These findings suggest that guideline recommended treatment intensification remains low for patients with mCSPC in both Medicare and the Veterans Health Administration, but especially for Black patients,” says Daniel J. George, MD.

“In the future, this imaging technique can help to streamline the drug development process, driving conviction in the agents we bring to larger scale trials," says Stephen Rose, PhD.

"In terms of the minimal overlapping toxicity, our non-clinical data from the xenograft model showed minimal toxicity with the combination," says Caroline Foxton, PhD.

"Our clinical trial is the first to show a longer time to biochemical recurrence with chemotherapy plus standard hormone therapy for patients with locally advanced, high-risk prostate cancer," says Jiahua Pan, MD.

iTind is a temporary nitinol device used to treat lower urinary tract symptoms caused by benign prostatic hyperplasia.

The 3 new additional studies are the ABLE-22, ABLE-32, and ABLE-42 clinical trials.

"As a kidney cancer community, we need to investigate these molecular subtypes prospectively in clinical trials to determine whether specific subtypes benefit from certain therapies or not," says David A. Braun, MD, PhD.

The IND will initiate the launch of a phase 3 study to explore the safety and efficacy of UGN-103 in patients with low-grade, intermediate-risk NMIBC.

The study is exploring the small activating RNA therapy RAG-01 in patients with BCG-unresponsive non–muscle-invasive bladder cancer.