The median OS was 34 months with 177Lu-PSMA-617 plus enzalutamide compared with 26 months with enzalutamide alone.

The FDA is requiring a warning about increased blood pressure and is recommending that the black box warning related to the increased risk of adverse cardiovascular events be removed.

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.

"For telephone-only (audio only) visits, Medicare has officially stated that such a visit would be considered the same as an in-person visit, with a few qualifications," write Jonathan Rubenstein, MD, and Mark Painter.

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.

"At ASCO GU, we presented the final analysis of the study, which confirmed the superiority of a combination over the TKI monotherapy in terms of both progression-free survival as well as overall survival," says Camillo Porta, MD.

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.

Total detection rate was 36% (13/36) in the ultra-low PSA group and 51% (47/93) in the low-PSA group.

"Sometimes, there is more than a single answer to a question; this certainly applies to patients with benign prostatic disease," writes Gopal H. Badlani, MD.

Robert J. Motzer, MD, reported that median PFS was 16.4 months in the nivolumab plus cabozantinib arm (95% CI, 12.5-19.3) vs 8.3 months in the sunitinib arm (95% CI, 7.0-9.7) (HR=0.58, 95% CI, 0.49-0.70).

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

"The updated results from CLEAR trial confirming that the amount of tumor shrinkage correlates with prognosis through overall survival, PFS, as well as through IMDC prognostic scoring should add further weight to lenvatinib and pembrolizumab being a go-to standard of care in this setting," says Thomas E. Hutson, DO, PharmD.

"With the requirements for an E/M code as noted above, we agree with you that the supporting documentation, if appropriately documented, would support a level 3 outpatient visit for a visit regarding counseling for contraception or family planning," write Jonathan Rubenstein, MD, and Mark Painter.

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.

Median PFS was 35 months in the MDT plus SOC group vs 21 months in the SOC alone group.

PSMA staging did not appear to have a significant impact on radiation therapy utilization.

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

“Among active surveillance patients, 82% are metastases free, and 60% were metastases free and had an intact, un-radiated bladder,” said Pooja Ghatalia, MD.