Urology Times Annual Pipeline Report


This year, the FDA authorized a multitude of new treatments and devices for use in urology practice. Here are the highlights.


LithoVue Elite System for ureteroscopy



The FDA granted 510(k) clearance to the LithoVue Elite Single-Use Digital Flexible Ureteroscope System.1 The device is the first of its kind, with the ability to monitor intrarenal pressure (IRP) in real time during ureteroscopy procedures to manage kidney stones, according to Boston Scientific Corporation. The LithoVue system includes a built-in pressure sensor on the tip of the ureteroscope to help urologists make informed clinical decisions during ureteroscopies, where fluid irrigation intended to provide a clear visual field can lead to elevated IRP.


New Illuccix indication for metastatic prostate cancer

The FDA approved a supplemental new drug application for Illuccix, a radiopharmaceutical cold kit for the preparation of gallium-68 (68Ga) gozetotide (PSMA-11) injection.2 The product is now approved for the selection of patients with metastatic prostate cancer for whom lutetium Lu 177 vipivotide tetraxetan (177Lu-PSMA-617; Pluvicto) is indicated. Illuccix was previously approved for use following radiolabeling with gallium-68 as a radioactive diagnostic agent for prostate-specific membrane antigen (PSMA)-PET imaging in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy, or with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.3

Pembrolizumab receives full approval for MSI-H/dMMR solid tumors

The FDA converted an accelerated approval of pembrolizumab (Keytruda) into a full approval for the treatment of patients with microsatellite instability–high or mismatch repair–deficient solid tumors, including prostate and other genitourinary cancers.4 The full approval, which is for patients with unresectable or metastatic tumors who have progressed following previous treatment and who have no satisfactory alternative options, was based on a pooled analysis of 504 adult and pediatric patients enrolled across 3 phase 2 trials: KEYNOTE-158 (NCT02628067), KEYNOTE-164 (NCT02460198), and KEYNOTE-051 (NCT02332668).


Pembrolizumab/enfortumab vedotin for frontline urothelial cancer

The FDA granted an accelerated approval to the combination of enfortumab vedotin-ejfv (Padcev) and pembrolizumab for the first-line treatment of patients with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin-containing chemotherapy.5 The approval was supported by results from the combined dose escalation/cohort A and cohort K of the phase 1b/2 EV-103 trial (KEYNOTE-869; NCT03288545).

Vivally System for overactive bladder

The FDA granted 510(k) clearance to the Vivally System, a wearable, noninvasive, bladder control therapy device and mobile application to treat patients with urinary urgency and urge urinary incontinence caused by overactive bladder syndrome.6 The system involves an ankle-worn garment that emits an electrical signal to the patient’s tibial nerve. The patient’s physician calculates a therapy range personalized to a particular patient and then the system is prescribed for use in the patient’s home.


Bladder EpiCheck for NMIBC surveillance

The FDA granted 510(k) clearance to Bladder Epicheck, a noninvasive method for detecting tumor recurrence in patients diagnosed with non–muscle-invasive bladder cancer.7 According to Nucleix, the developer of the test, Bladder Epicheck is “a highly sensitive and specific test that analyzes subtle disease-specific changes across 15 methylation markers that are associated with bladder cancer.” The methylation-based urine test is performed on a quantitative polymerase chain reaction platform and is intended for use in conjunction with cystoscopy.

Flotufolastat F 18 for PSMA-PET imaging in prostate cancer

The FDA granted approval flotufolastat F 18 (formerly 18F-rhPSMA-7.3; Posluma) for PET imaging of PSMA-positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy or with suspected recurrence based on elevated serum PSA level.8 The approval of flotufolastat F 18 is based on findings from the phase 3 SPOTLIGHT (NCT04186845) and LIGHTHOUSE (NC04186819) trials.

Olaparib/abiraterone for BRCA-positive mCRPC

The FDA approved olaparib (Lynparza) for use in combination with abiraterone acetate (Zytiga) and prednisone or prednisolone for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC), as determined by an FDA-approved companion diagnostic test.9 The approval was based on the phase 3 PROpel trial (NCT03732820). A subanalysis from the trial in patients with BRCA mutations showed that the addition of olaparib to abiraterone and prednisone/prednisolone led to a 76% reduction in the risk of disease progression or death and a 70% reduction in the risk of death vs abiraterone and prednisone/prednisolone alone.


Topical gel for erectile dysfunction

The FDA granted over-the-counter marketing authorization to the topical gel formulation MED3000 (Eroxon) for the treatment of erectile dysfunction.10 MED3000 has a quick 10-minute turnaround time from application to the “onset of action,” according to Futura Medical plc, the developer of the gel. The company stated in a press release that this turnaround time compares favorably with the 30-minute or greater turnaround time of phosphodiesterase 5 inhibitors (tadalafil [Cialis] and sildenafil citrate [Viagra]).10

Talazoparib/enzalutamide for HRR gene–mutated mCRPC

The FDA approved talazoparib (Talzenna) plus enzalutamide (Xtandi) for the treatment of patients with homologous recombination repair (HRR) gene-mutated mCRPC.11 The approval was based on the phase 3 TALAPRO-2 trial (NCT03395197), in which the combination reduced the risk of disease progression or death by 55% vs enzalutamide plus placebo in a subgroup of patients with HRR gene–altered mCRPC. The median radiographic progression-free survival (PFS) was not yet reached in patients receiving talazoparib/enzalutamide vs 13.8 months in the control arm (HR, 0.45; P < .0001).


Optilume BPH Catheter System

The FDA approved the Optilume BPH Catheter System for the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia (BPH). 12 The Optilume BPH system is a minimally invasive surgical therapy consisting of a drug-coated (paclitaxel) balloon system. “Mechanical dilation with [the system] achieves an anterior commissurotomy while delivery of paclitaxel is intended to maintain luminal patency during healing,” Urotronic, Inc, the developer of the treatment, explained in a news release.12


Niraparib/abiraterone tablet for BRCA-positive mCRPC

The FDA approved a dual-action tablet (Akeega) that combines niraparib (Zejula) with abiraterone acetate for use with prednisone for the treatment of adult patients with BRCA mutation–positive mCRPC, as detected by an FDA-approved test.13 The approval was supported by the phase 3 MAGNITUDE study (NCT03748641), which showed that adding niraparib to abiraterone significantly extended radiographic PFS in patients with mCRPC and HRR gene alterations, such as BRCA1/2. Further, FoundationOne CDx was approved for use as a companion diagnostic to identify patients eligible to receive the tablet for this indication.14

Revi System for urge urinary incontinence

The FDA granted a De Novo marketing authorization to the Revi System (formerly Renova iStim), a tibial neurostimulator device for men and women with urge urinary incontinence (UUI).15 The agency’s decision was based on results from the OASIS trial, in which Revi demonstrated significant efficacy for treating UUI in women. Specifically, 76.4% of patients had a 50% or higher reduction in incontinence episodes at 6 months. Additionally, the data at 12 months showed that among patients who completed the study, 82% had at least a 50% reduction in UUI episodes and half (49.6%) were 100% dry during a 3 consecutive day evaluation.

BioProtect Balloon Implant System for prostate cancer

The FDA granted 510(k) clearance to the BioProtect Balloon Implant System, a biodegradable balloon spacer for rectal protection during radiation therapy for prostate cancer.16 “We believe our balloon has the potential to revolutionize rectal protection from toxicity during prostate cancer radiation therapy. Not only does it provide better protection to healthy organs, [but] it also supports dose escalation and hypofractionation, which are leading trends in prostate cancer radiation therapy,” Itay Barnea, CEO of BioProtect Ltd, said in a news release.16


Nedosiran for primary hyperoxaluria type 1

The FDA approved nedosiran (Rivfloza) injection for the treatment of adult patients and children aged at least 9 years with primary hyperoxaluria type 1 (PH1) who have relatively preserved kidney function.17 Nedosiran is a once-monthly subcutaneous RNA interference therapy designed to lower urinary oxalate levels in patients with PH1, which is a rare, inherited condition that leads to recurrent kidney stones and/or nephrocalcinosis and may lead to chronic kidney damage.


Enzalutamide for nonmetastatic CSPC

The FDA approved enzalutamide for use with or without a gonadotropin-releasing hormone analog therapy for the treatment of patients with nonmetastatic castration-sensitive prostate cancer with biochemical recurrence at high risk for metastasis.18 The approval was based on findings from the phase 3 EMBARK trial (NCT02319837), which showed that enzalutamide plus leuprolide reduced the risk of metastasis or death by 58% compared with placebo plus leuprolide in this patient population (HR, 0.42; P < .001). The median metastasis-free survival (MFS) was not yet reached in the enzalutamide/leuprolide arm vs in the leuprolide-alone arm. The 5-year MFS rates were 87.3% vs 71.4%, respectively.


1. Boston Scientific receives FDA clearance for LithoVue Elite Single-Use Digital Flexible Ureteroscope System. News release. Boston Scientific Corporation. February 3, 2023. Accessed November 22, 2023. https://tinyurl.com/mry6emte

2. FDA approves expanded indication for Telix’s Illuccix to include patient selection for PSMA-directed radioligand therapy. News release. Telix Pharmaceuticals Limited. March 16, 2023. Accessed March 16, 2023. https://prn.to/40a1v15

3. FDA approves first PSMA-targeted PET imaging drug for men with prostate cancer. News release. FDA. December 1, 2020. Accessed December 1, 2020. https://bit.ly/3fWUOcN

4. FDA converts to full approval indication for Keytruda (pembrolizumab) for certain adult and pediatric patients with advanced microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors. News release. Merck. March 29, 2023. Accessed March 29, 2023. https://tinyurl.com/2ntracdw

5. FDA grants accelerated approval to enfortumab vedotin-ejfv with pembrolizumab for locally advanced or metastatic urothelial carcinoma. FDA. April 3, 2023. Accessed April 3, 2023. https://bit.ly/3MdWuAJ

6. Avation Medical announces US FDA 510(k) clearance for the Vivally System, a wearable bladder control therapy and mobile app to treat patients with urinary urgency and urge urinary incontinence. News release. Avation Medical, Inc. April 11, 2023. Accessed April 12, 2023. https://prn.to/3Uygoc7

7. Nucleix’s Bladder EpiCheck receives FDA 510(k) clearance for monitoring of non-muscle invasive bladder cancer (NMIBC) recurrence. News release. Nucleix. May 4, 2023. Accessed May 5, 2023. https://tinyurl.com/5n8cayjn

8. U.S. FDA approves Blue Earth Diagnostics’ Posluma (flotufolastat F 18) injection, first radiohybrid PSMA-targeted PET imaging agent for prostate cancer. News release. Blue Earth Diagnostics. May 30, 2023. Accessed May 30, 2023. https://tinyurl.com/mpbdk5br

9. FDA approves olaparib with abiraterone and prednisone (or prednisolone) for BRCA-mutated metastatic castration-resistant prostate cancer. FDA. May 31, 2023. Accessed May 31, 2023. https://tinyurl.com/yc5bz8md

10. US FDA grants for over-the-counter marketing authorization to Futura for fast-acting topical gel, MED3000, to treat erectile dysfunction. News release. Futura Medical plc. June 12, 2023. Accessed June 16, 2023. https://tinyurl.com/5h5b8cyf

11. Pfizer’s Talzenna in combination with Xtandi receives U.S. FDA approval. News release. Pfizer. June 20, 2023. Accessed June 21, 2023. https://tinyurl.com/2rdbyem3

12. Urotronic announces FDA approval of Optilume BPH Catheter System, pioneering the next generation of minimally invasive solutions for enlarged prostate symptom relief. News release. Urotronic, Inc. July 11, 2023. Accessed July 11, 2023. https://tinyurl.com/2s47cj52

13. U.S. FDA approves Akeega (niraparib and abiraterone acetate), the first-and-only dual action tablet for the treatment of patients with BRCA-positive metastatic castration-resistant prostate cancer. News release. Janssen Pharmaceutical Companies of Johnson & Johnson. August 11, 2023. Accessed August 11, 2023. https://tinyurl.com/2s3mmn4d

14. U.S. Food and Drug Administration (FDA) approves FoundationOne CDx as a companion diagnostic for Janssen’s Akeega (niraparib and abiraterone acetate dual action tablet) for patients with BRCA-positive metastatic castration-resistant prostate cancer. News release. Foundation Medicine Inc. August 15, 2023. Accessed August 15, 2023. https://tinyurl.com/yc8e6cc5

15. BlueWind Medical’s Revi System secures U.S. FDA De Novo classification grant for the treatment of urgency incontinence. News release. BlueWind Medical. August 17, 2023. Accessed August 22, 2023. https://tinyurl.com/y2ebpxy8

16. BioProtect receives FDA’s clearance for its biodegradable balloon for rectal protection during prostate cancer radiation therapy. News release. BioProtect. August 28, 2023. Accessed August 28, 2023. https://tinyurl.com/mryc3vwa

17. FDA approves Rivfloza for children ≥9 years old and adults living with primary hyperoxaluria type 1 (PH1), a rare genetic condition. News release. Novo Nordisk. October 2, 2023. Accessed October 2, 2023. https://tinyurl.com/mr5heuhk

18. Pfizer and Astellas’ Xtandi approved by U.S. FDA in earlier prostate cancer treatment setting. News release. Pfizer. November 16, 2023. Accessed November 17, 2023. https://tinyurl.com/52c83f2z

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