Jason M. Broderick

The authors aimed to show that the positive safety/tolerability profile for darolutamide established in nonmetastatic patients also extended to the metastatic setting.

The PHS290 polygenic hazard score is based on 290 genetic variants linked with prostate cancer risk.

“While Jelmyto is approved for both retrograde and antegrade instillation, the instructions for administration address retrograde instillation, and this is the first time that data on antegrade instillation has been documented in a clinical setting for this chemoablative therapy,” said Katie Murray, DO.

“Such findings underscore the need for and importance of molecular testing to inform management along with continued research to establish treatment paradigms with appropriately targeted therapies for patients with prostate cancer,” the authors wrote.

The phase 1/2 COBRA trial is exploring the novel PSMA-PET imaging agent 64Cu-SAR-bisPSMA in patients with biochemical recurrence.

The phase 3 ENVISION study is exploring the mitomycin-containing reverse thermal gel UGN-102 as primary chemoablative therapy in patients with low-grade, intermediate-risk non-muscle invasive bladder cancer.

The efficacy of the neoadjuvant triplet was observed regardless of PD-L1 status.

The designation was awarded to the Acoustic Enhancer, a micro bubble composed of a gas core with a lipid shell, which is intended for use in conjunction with standard laser lithotripsy.

The approval is based on the pivotal phase 3 KEYNOTE-564 trial.

Cost was the most commonly reported barrier to genetic testing.

The investigational imaging radiopharmaceutical TLX250-CDx targets the receptor carbonic anhydrase IX (CA9), which is overexpressed in urologic cancers.

The study is enrolling patients with metastatic castration-resistant prostate cancer who have not received second-generation anti-androgen therapies.

Erdafitinib is approved by the FDA for the treatment of adult patients with FGFR3/FGFR2-positive locally advanced or metastatic bladder cancer that has progressed on platinum-containing chemotherapy.

This real-world cohort study corroborates prior research showing a greater clinical benefit for abiraterone acetate in African American versus White patients with metastatic castration-resistant prostate cancer.

The trial is exploring tivozanib combined with the investigational HIF2α-inhibitor NKT2152 in patients with renal cell carcinoma who have not responded to or have relapsed from prior treatments.

The phase 3 CONTACT-03 trial is specifically accruing patients with inoperable, locally advanced or metastatic renal cell carcinoma with disease progression after receiving an immune checkpoint inhibitor as the immediate prior therapy.

The leva Pelvic Health System showed early promise as a noninvasive therapy to alleviate symptoms of fecal incontinence in women.

The approval of the first PARP inhibitors for prostate cancer was hailed as the "dawn of the precision medicine era" in the field.

The new drug application is supported by a prior submission for premarket approval of Dovitinib-DRP, a companion diagnostic used to identify patients with RCC most likely to respond to dovitinib.

The phase 3b study is exploring home instillation of UGN-102 for patients with low-grade, intermediate-risk non–muscle-invasive bladder cancer.

TLX591-CDx (Illuccix) is a radiopharmaceutical cold kit for the preparation of gallium-68 PSMA-11 injection.

“Falls are the leading cause of accidental death in seniors, and many people don’t know that having bladder control problems makes you about twice as likely to fall over,” said William Gibson, MBChB, MRCP, PhD.

Adjuvant pembrolizumab was recommended for approval in renal cell carcinoma based on results from the phase 3 KEYNOTE-564 trial.

The antibody-drug conjugate was recommended for approval in the European Union based on findings from the phase 3 EV-301 trial.

The approval was based on data from the ROBUST I and ROBUST 3 clinical trials.

The once-daily capsule combines 5 mg of tadalafil with 5 mg of finasteride.

Catch up on all the notable drug and device approvals in urology over the past year.

The FDA issued a complete response letter earlier this year regarding a biologics license application for the protein fusion drug in patients with BCG-unresponsive non–muscle invasive bladder cancer.

The PROPELLER trial is exploring the novel PSMA-PET imaging product 64Cu-SAR-bisPSMA in patients with treatment-naïve, histologically confirmed prostate cancer who are scheduled for radical prostatectomy.