Long-term data show darolutamide is safe for patients with metastatic CRPC
The authors aimed to show that the positive safety/tolerability profile for darolutamide established in nonmetastatic patients also extended to the metastatic setting.
Novel genetic risk score may help guide prostate cancer screening decisions
The PHS290 polygenic hazard score is based on 290 genetic variants linked with prostate cancer risk.
Study demonstrates feasibility of antegrade instillation of Jelmyto for UTUC
“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.
PARP inhibitor niraparib shows promise in mCRPC with DNA repair gene defects
“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.
FDA authorizes trial of novel PSMA-PET imaging diagnostic in prostate cancer
The phase 1/2 COBRA trial is exploring the novel PSMA-PET imaging agent 64Cu-SAR-bisPSMA in patients with biochemical recurrence.
Phase 3 study launches of UGN-102 in low-grade NMIBC
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.
Neoadjuvant atezolizumab plus chemotherapy shows promise in MIBC
The efficacy of the neoadjuvant triplet was observed regardless of PD-L1 status.
FDA grants breakthrough device designation to laser lithotripsy enhancer
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.
Adjuvant pembrolizumab approved in EU for renal cell carcinoma
The approval is based on the pivotal phase 3 KEYNOTE-564 trial.
Worldwide genetic testing rates are low for patients with prostate cancer
Cost was the most commonly reported barrier to genetic testing.
Study launches of novel imaging radiopharmaceutical in NMIBC
The investigational imaging radiopharmaceutical TLX250-CDx targets the receptor carbonic anhydrase IX (CA9), which is overexpressed in urologic cancers.
Combo of novel NTD inhibitor plus enzalutamide explored in mCRPC
The study is enrolling patients with metastatic castration-resistant prostate cancer who have not received second-generation anti-androgen therapies.
Erdafitinib efficacy in bladder cancer sustained with long-term follow-up
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.
Survival with frontline abiraterone higher for African American vs White men with mCRPC
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.
Study launching of tivozanib plus novel HIF2α-inhibitor in kidney 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.
Enrollment completed for phase 3 trial of cabozantinib plus atezolizumab in renal cell carcinoma
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.
Motion-based digital therapeutic shows potential for women with fecal incontinence
The leva Pelvic Health System showed early promise as a noninvasive therapy to alleviate symptoms of fecal incontinence in women.
NCCN collaborates with Pfizer to advance PARP inhibitors in prostate cancer
The approval of the first PARP inhibitors for prostate cancer was hailed as the "dawn of the precision medicine era" in the field.
Dovitinib application submitted to FDA for third-line renal cell carcinoma
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.
Home instillation study launches for UGN-102 in NMIBC
The phase 3b study is exploring home instillation of UGN-102 for patients with low-grade, intermediate-risk non–muscle-invasive bladder cancer.
FDA approves novel PSMA-PET imaging product for prostate cancer
TLX591-CDx (Illuccix) is a radiopharmaceutical cold kit for the preparation of gallium-68 PSMA-11 injection.
Patient-perception data indicate meaningful benefit for vibegron in patients with OAB
Urinary incontinence linked to increased risk of falling in older adults
“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 approaches European approval for renal cell carcinoma
Adjuvant pembrolizumab was recommended for approval in renal cell carcinoma based on results from the phase 3 KEYNOTE-564 trial.
Enfortumab vedotin nears EU approval for locally advanced or metastatic urothelial cancer
The antibody-drug conjugate was recommended for approval in the European Union based on findings from the phase 3 EV-301 trial.
FDA approves Optilume drug-coated balloon catheter for urethral strictures
The approval was based on data from the ROBUST I and ROBUST 3 clinical trials.
FDA approves tadalafil/finasteride combo capsule for BPH
The once-daily capsule combines 5 mg of tadalafil with 5 mg of finasteride.
2021 urology pipeline report
Catch up on all the notable drug and device approvals in urology over the past year.
Next steps announced for Vicineum in bladder cancer
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.
Trial of novel PSMA-PET imaging agent in prostate cancer hits enrollment milestone
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.
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