Hannah Clarke

“This highlights a need for physicians to better integrate patient preferences into their treatment recommendations," says Jonathan Bergman, MD, MPH.

The CHMP’s positive recommendation is based on findings from the first interim analysis of the phase 3 EV-302 trial.

"Receiving the new CPT code and national payment rate for Unfold AI is an important development in making advanced personalized prostate cancer care accessible to more patients," said Brit Berry-Pusey, PhD.

The PDUFA goal date for TLX007-CDx is March 24, 2025.

Data from phase 2 of the SANS-UUI trial are expected to support an application to the FDA for approval of the device in patients with urge urinary incontinence.

"This is an exciting step in the evolution of urological surgery for both adult and pediatric patients,” says Chester J. Koh, MD, MBA, FACS, FAAP.

"We will be looking not only at how well this software performs in a busy clinical setting and whether diagnostic accuracy and efficiency improves, but also assessing the experience of clinicians and patients, and looking at the impact on workflow," says Clare Verrill, BM, FRCPath, MMedEd.

The study has enrolled 8 patients to assess the safety and efficacy of the device in sealed vasectomy procedures.

"While the addition of an ICI to low dose FOTIVDA did not improve PFS outcomes after prior ICI, we consider the control arm data an important, evidence-based and clinically meaningful contribution to the oncology community treating relapsed or refractory advanced RCC following front-line ICI combinations," says Michael P. Bailey.

here was a higher concordance of somatic alterations between tissue and ctDNA testing in patients with metastases vs those without.

ORIC-944 was initially being evaluated as a monotherapy in the phase 1b trial.

Topline results from the phase 3 ARANOTE trial showed a statistically and clinically significant improvement in rPFS with the addition of darolutamide to ADT vs ADT alone.

Data showed a 90.6% rate of correct consumer self-selection among those who used the Web App Technology with the DFL vs 57.3% among those that used the DFL alone.

“These findings provide a plausible mechanism for the enhanced clinical outcome with CBM588 now seen across 2 small, randomized trials,” write the authors.

All patients have now been enrolled in cohort 6 of the trial, and dosing with ONCT-534 has begun at the dose level of 1200 mg.

“Our findings suggest an impact of living in disadvantaged neighborhoods—which more commonly affects African Americans—on stress-related genetic pathways in the body. We believe this may increase an individual’s risk of aggressive prostate cancer and contribute to prostate cancer disparities by race,” says Kathryn Hughes Barry, PhD, MPH.

At 12-week follow-up, TAS-303 demonstrated a least squares mean percent change in SUI episode frequency per 24 hours of -57.7% vs -46.9% with placebo.

“By understanding the mirSNP genetic markers that predispose patients to adverse side effects from cancer therapy we can tailor these therapies to minimize harm and maximize efficacy," says Joanne B. Weidhaas, MD, PhD, MS.

All 3 codes for the procedure will become effective on January 1, 2025.

The guideline includes 38 recommendations on managing incontinence following treatment for localized prostate cancer or benign prostatic hyperplasia.

"We believe the collective findings are unique in urogynecology and offer strong evidence that first-line incontinence treatment is effective, and women can access it using the Leva System,” says Evelyn Hall, MD.

The cisplatin drug shortage was first announced on February 10, 2023.

The phase 1b trial enrolled 51 female patients with OAB to assess the safety, tolerability, and preliminary efficacy of V117957.

There was an overall response rate of 39% among the 18 evaluable patients, including 1 complete response and 6 partial responses.

This announcement comes on the heels of an FDA acceptance of an investigational new drug application for ADI-270 in June.

MK-5684/ODM-208 is a selective CYP11A1 inhibitor currently under investigation in the phase 3 OMAHA1 and OMAHA2a trials.

In May 2024, the FDA cleared an investigational new drug application for 225Ac-FL-020.

"This clearance in the US of our new ureteroscopy solution not only demonstrates a market expansion for Ambu; it is a testament to the progressive shift towards single-use solutions within the field of urology," says Britt Meelby Jensen.

The decision is supported by findings from the phase 3 EMPOWUR trial and the phase 3 EMPOWUR extension study.

Earlier this year, the FDA cleared an investigational new drug application for SYNC-T SV-1022.