Hannah Clarke

Tom Jayram, MD, discusses rationale for selective FGFR3 inhibition in bladder cancer as well as what’s needed to bring this treatment modality into routine clinical practice.

Two-year outcomes from the ASPIRE trial continued to show that the SURE procedure led to significantly reduced health care consumption events compared with ureteroscopy.

The NDA is supported by data from a phase 3 trial, which demonstrated a 75% complete response rate at 3 months.

The registrational trial is aiming to expand the indications for Illuccix and Gozellix to include use in prostate cancer diagnosis.

Data showed a marked or moderate improvement in IC/BPS symptoms in 41% of patients who received sunobinop vs 9% of patients who received placebo.

Data from the SunRISe-1 trial showed a complete response rate of 82%, with 51% of patients remaining in complete response for at least 1 year.

Patients will be enrolled in the study through clinical trial sites in the US, with additional international sites to follow.

At the time of data report, the median progression-free survival and duration of response had not been reached in either cohort.

The combination also yielded durable responses in a subset of patients with sporadic papillary renal cell carcinoma.

CG Oncology plans to initiate a BLA submission with the FDA in Q4 of 2025.

The AUA has released updated guidelines for recurrent UTIs in women, emphasizing patient-centered care, nonantibiotic options, and improved clinical judgment.

The LEGEND trial is evaluating detalimogene voraplasmid in patients with high-risk non–muscle invasive bladder cancer.

The trial is assessing RFS rates with cretostimogene grenadenorepvec vs surveillance following TURBT.

The report showed rising incidence rates and a slowing of mortality declines in addition to persistent racial disparities.

Take a look through key stories from last month, including regulatory news, trial updates, and other practice-changing advancements.

Predicine has submitted the first module of a PMA application for their urine cfDNA NGS assay PredicineCARE.

A recap of the FDA submissions and regulatory decisions in urology from August 2025.

The new guidelines provide evidence-based recommendations for treating patients with traumatic injuries to the kidneys, bladder, ureters, urethra, and genitalia.

The approval is supported by findings from an open-label, single-arm, phase 3 trial.

The findings highlight a lack of awareness on the signs and symptoms of prostate cancer, as well as common misconceptions about testicular cancer.

The FDA has declined to approve 89Zr-DFO-girentuximab for PET imaging of ccRCC.

The findings were derived from the multicenter, prospective, phase 3 STAMPEDE trial.

“This shows that AI analysis of routine biopsies can detect subtle signs indicating clinically significant prostate cancer before it becomes obvious to a pathologist," says Carolina Wählby, PhD.

Take a look through the novel agents that are set to further redefine the treatment landscape for high-risk BCG-unresponsive NMIBC.

Darolutamide plus ADT has also been approved in the US as well as in the European Union.

“We hope our findings reassure health professionals caring for postmenopausal women with a history of stroke,” says Kimia Ghias Haddadan, MD.

The presentations featured data on the drug candidate BOTRESO for BPH and LUTS, as well as on the prostate cancer prevention drug MCS-8.

The company is engaged in discussions with the FDA surrounding the initiation of a pivotal phase 3 trial of Alpha1H.

Concurrent use of an ARPI with [177Lu]Lu-PSMA-617 did not improve response rates nor overall survival in patients with ARPI-refractory mCRPC.

The approval of oral sulopenem was supported by data from the phase 3 SURE 1 (NCT03366207) and REASSURE (NCT05584657) trials.