Hannah Clarke

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

Overall, 84.2% of patients achieved a 50% or greater reduction in urgent leaks.

The updates emphasize a risk-stratified approach to the management of microhematuria.

Data from the VAPOR 2 trial are intended to support a submission to the FDA for 510(k) clearance of the device.

The PDUFA date is August 27, 2025.

YOLT-203 was granted an Orphan Drug Designation and a Rare Pediatric Disease Designation in September 2024.

Myriad is planning to launch its first AI-driven prostate cancer clinical test later this year.

The trial plans to enroll up to 80 adult patients with mCRPC who have progressed on prior systemic therapies.

The pCR rate was 33% with APL-1202 plus tislelizumab compared with 26% with tislelizumab alone.

The results encompassed the first 100 patients enrolled in the registry.

The designation is supported by preliminary data from the ongoing phase 1/2a SECuRE trial.

According to ImmunityBio, shipments of rBCG are set to begin immediately via the EAP.

The conditional approval of belzutifan is valid for 1 year, with the opportunity for yearly renewal pending forthcoming data.

However, the triplet regimen did not lead to an improvement in overall survival.

Anktiva is also currently under review for the CIS indication in the EU.

“These data reinforce enfortumab vedotin and pembrolizumab as the new standard of care in frontline urothelial cancer," says Thomas Powles, MD, PhD.

The median duration of response was 47.8 months among patients who achieved an initial complete response.

Illuccix has been previously approved in the US, Australia, Canada, and Europe.

Overall, 85% of respondents indicated they experienced frequent bladder leaks.

The software generates heatmaps to help identify prostatic tumors that may have been missed on initial reads.

At 24 months, 79% of patients experienced a response to therapy, and 56% achieved at least a 75% reduction in UUI episodes.

At a median follow-up of 40.2 months post-surgery, no patients had experienced a disease recurrence.

A phase 1/2 trial of ABO-101 is expected to launch in the first half of 2025.

In total, 28% of patients with luminal tumors and 41% of patients with nonluminal tumors experienced upstaging to nonorgan confined disease.

The primary end point is 12-month radiographic progression-free survival.

The data also showed that mortality plateaued in recent years despite declining in years prior.

Overall, 403 medical students and other applicants were matched across 148 urology residency programs nationwide.

The incidence of late grade 2 or greater GU toxicity at 5 years was 12.5% among those who did experience acute toxicity vs 7.5% among those who did not.

"What we show in our research is that cancers develop in different ways, depending on what the underlying genetic change is," says Taryn Treger.

“MPS2 could potentially improve the health of our patients by avoiding overdiagnosis and overtreatment and allowing us to focus on those who are most likely to have aggressive cancers," says Ganesh S. Palapattu, MD, FACS.