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Benjamin P. Saylor is associate editor of Urology Times, an Advanstar Communications publication.

Five-year data from the phase 3 KEYNOTE-426 trial confirm the clinical benefits of front-line pembrolizumab plus axitinib in advanced ccRCC.

Pembrolizumab plus axitinib shows sustained benefit vs sunitinib in ccRCC

INKmune was well-tolerated across all 3 dose levels assessed.

Phase 1/2 trial of INKmune therapy for mCRPC meets primary end point

 is compliance officer and medical director of coding and reimbursement, United Urology Group and Chesapeake Urology, in Towson, Maryland.

"As with all medications and services, it is important to check with the patient’s insurer to determine their policy and whether the medication will be covered," write Jonathan Rubenstein, MD, and Mark Painter.

How to bill for mitomycin for intravesical solution in NMIBC

Data showed that 1 in 6 men with GG1 prostate cancer ultimately had higher-risk disease when other clinical features were taken into account.

Biopsy grade alone may underestimate risk in GG1 prostate cancer

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"The global shortage of ICM has necessitated rapid adaptation of workflows and clinical pathways, which are particularly important for practicing urologists who are evaluating patients for hematuria," write Yair Lotan, MD, and colleagues.

Strategies to mitigate impact of intravenous ICM shortage

The FDA has accepted a new drug application (NDA) for zoliflodacin, an investigational first-in-class, single-dose, spiropyrimidinetrione oral antibiotic for the treatment of adult and pediatric patients 12 years and older with uncomplicated gonorrhea, Innoviva Specialty Therapeutics announced in a news release.

The Prescription Drug User Fee Act (PDUFA) target action date for the application is December 15, 2025.

Zoliflodacin is an oral antibiotic that inhibits type II topoisomerase, a bacterial enzyme that plays a key role in bacterial function and reproduction. According to the company, “If approved, zoliflodacin would be the first new antibiotic for treating gonorrhea in decades.”

The FDA has also granted a Qualified Infectious Disease Product designation to zoliflodacin, which enables the agent to benefit from priority review and market exclusivity.

“Today’s acceptance of the zoliflodacin NDA marks significant progress toward delivering health care providers with a potential new oral treatment option for uncomplicated gonorrhea, including infections caused by drug-resistant strains,” said David Altarac, MD, Chief Medical Officer of Innoviva Specialty Therapeutics, in the news release.

 “We look forward to working closely with the FDA during its review and, if approved, we are committed to expediting the availability of zoliflodacin to patients in the U.S.”

The NDA for zoliflodacin is supported by data from several clinical trials conducted through a collaboration with the Global Antibiotic Research & Development Partnership (GARDP). This portfolio of studies includes a pivotal phase 3 trial (NCT03959527) that evaluated zoliflodacin vs a standard of care (SOC) regimen (500 mg ceftriaxone intramuscular plus 1g oral azithromycin) in patients with uncomplicated gonorrhea.

Overall, the trial met its primary end point by demonstrating that zoliflodacin was non-inferior to the SOC regimen regarding microbiological response at the urogenital site at the test of cure visit (6 +/- 2 days following treatment). Specifically, the microbiological cure rate was 90.9% in the zoliflodacin arm vs 96.2% in the ceftriaxone/azithromycin arm, representing a difference of 5.3% (95% CI, 1.4% to 8.7%) across patients in the micro-intent-to-treat (ITT) population.

The 2 cohorts also demonstrated comparable results on the trial’s secondary end point of microbiological response at extragenital (rectal or pharyngeal) sites. Specifically, at pharyngeal sites, the cure rate was 79.2% in the zoliflodacin arm vs 78.6% in the ceftriaxone/azithromycin arm (difference, -0.67%; 95% CI, -20.8 to 16.3). At rectal sites, the cure rate was 87.3% and 88.6%, respectively (difference, 1.23%; 95% CI, -14.4 to 12.6).

Zoliflodacin was generally well-tolerated in the trial. Treatment-emergent adverse events (TEAEs) occurred in 46.2% of patients in the zoliflodacin arm vs 46.4% of patients in the ceftriaxone/azithromycin arm. The most common TEAEs in the zoliflodacin arm included headache (9.9%), neutropenia (6.8%), and leukopenia (3.9%).

There were no deaths or serious adverse events reported in either arm.

In total, the phase 3 trial included 930 patients with uncomplicated gonorrhea, including patients living with HIV. The study enrolled participants across 16 clinical trial sites in the US, Belgium, the Netherlands, South Africa, and Thailand.

According to Innoviva, the phase 3 study was “the largest clinical trial ever conducted for a new treatment against gonorrhea infection.”

Those enrolled in the study were randomly assigned 2:1 to receive 3 g single-dose, oral zoliflodacin (n = 621) or to 500 mg ceftriaxone intramuscular plus 1g oral azithromycin (n = 309). The primary end point was microbiological cure by culture at urogenital sites in the micro-ITT populations, with a non-inferiority margin of 12%. The trial’s secondary end point was microbiological cure at extragenital sites.

“This important milestone demonstrates the crucial role that public-private partnerships can play in tackling the escalating global antimicrobial resistance crisis,” said Manica Balasegaram, Executive Director of GARDP, in the news release.

 “If zoliflodacin is approved, this collaboration paves the way for millions of people across the world to get access to a potentially powerful new drug to treat multidrug-resistant gonorrhea.”

1. Innoviva Specialty Therapeutics receives FDA New Drug Application acceptance for zoliflodacin, a first-in-class oral antibiotic for uncomplicated gonorrhea in adults. News release. Innoviva Specialty Therapeutics. Published online and accessed June 10, 2025. https://innovivaspecialtytherapeutics.com/innoviva-specialty-therapeutics-receives-fda-new-drug-application-acceptance-for-zoliflodacin-a-first-in-class-oral-antibiotic-for-uncomplicated-gonorrhea-in-adults/

2. FDA Grants Priority Review for Zoliflodacin New Drug Application for the Treatment of Uncomplicated Gonorrhea and Assigns Target PDUFA Date of December 15, 2025. News release. Innovia Specialty Therapeutics, Inc. Published online and accessed June 12, 2025. https://www.businesswire.com/news/home/20250612432209/en/FDA-Grants-Priority-Review-for-Zoliflodacin-New-Drug-Application-for-the-Treatment-of-Uncomplicated-Gonorrhea-and-Assigns-Target-PDUFA-Date-of-December-15-2025 

3. Luckey A, Broadhurst H, Daram P, et al. Oral zoliflodacin is non-inferior to a combination of ceftriaxone and azithromycin for treatment of uncomplicated urogenital gonorrhoea: results of a large global Phase 3 randomised controlled trial. Presented at: European Society of Clinical Microbiology and Infectious Disease Global Congress. April 27-30, 2024. Barcelona, Spain. https://gardp.org/wp-content/uploads/2024/04/Zoli001-Topline-ECCMID2024_final_V1.0_23Apr2024_.pdf

The FDA has accepted the NDA for zoliflodacin, a novel oral antibiotic for treating uncomplicated gonorrhea in patients aged 12 and older. Zoliflodacin, which inhibits type II topoisomerase, has been granted a Qualified Infectious Disease Product designation, allowing for priority review. Clinical trials, including a pivotal phase 3 study, demonstrated that zoliflodacin is non-inferior to the standard regimen of ceftriaxone and azithromycin. The trials showed comparable microbiological cure rates at urogenital and extragenital sites, with zoliflodacin being generally well-tolerated and no serious adverse events reported.

The NDA is supported by a pivotal phase 3 trial of zoliflodacin vs ceftriaxone plus azithromycin in patients with uncomplicated gonorrhea. 

News

FDA accepts new drug application for zoliflodacin for uncomplicated gonorrhea

Dr. De La Cerda provides an overview of a patient case involving a 68 year-old male presenting with severe back pain, with an analysis of the clinical presentation, workup, and medical history.

Bone Predominant mCRPC Patient Case

Video content above is prompted by the following:

What are your initial impressions of the case?

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The FDA has accepted a Biologics License Application (BLA) seeking approval of nivolumab (Opdivo) co-formulated with Halozyme’s proprietary recombinant human hyaluronidase (rHuPH20), or subcutaneous nivolumab, for the treatment of patients with all previously approved solid tumor indications for nivolumab as a monotherapy, monotherapy maintenance following completion of combination therapy with nivolumab plus ipilimumab (Yervoy), or in combination with chemotherapy or cabozantinib (Cabometyx).

Nivolumab is currently approved under several indications, including in combination with ipilimumab for the first-line treatment of patients with intermediate- or poor-risk advanced renal cell carcinoma (RCC), in combination with cabozantinib for the first-line treatment of patients with advanced RCC, for the treatment of patients with advanced RCC who have received prior anti-angiogenic therapy, and in combination with cisplatin and gemcitabine for the first-line treatment of patients with unresectable or metastatic urothelial carcinoma.

The FDA is set to have a decision regarding the subcutaneous nivolumab formulation on or by December 29, 2024.

 According to a news release from Bristol Myers Squibb,

 approval of the formulation would make it the first and only subcutaneously administered PD-1 inhibitor.

“We believe subcutaneous nivolumab has the potential to make a significant difference in the lives of patients, which is reinforced by the FDA’s acceptance of our application,” said Gina Fusaro, PhD, vice president, global program lead, Bristol Myers Squibb, in the news release.

 “Opdivo is a foundational PD-1 inhibitor approved for many different types of cancer, and our continued investment in research that puts patients first remains a priority. If approved by the FDA, the subcutaneous administration of nivolumab would provide patients and their physicians with a new option that delivers the same well-known benefits as IV Opdivo but with the improved convenience of an injection administered in 3 to 5 minutes rather than a 30-to-60-minute infusion.”

The BLA submission is supported by findings from the phase 3 CheckMate-67T trial (NCT04810078), in which subcutaneous nivolumab met the study’s co-primary end points by demonstrating noninferiority to intravenous (IV) nivolumab regarding time average nivolumab serum concentration over 28 days (C

; geometric mean ratio [GMR}, 2.098; 90% CI, 2.001-2.200) and minimum serum concentration at a steady state (C

Data from the study, which were presented at the 2024 American Society of Clinical Oncology Genitourinary Cancers Symposium in San Francisco, California,

 also showed that subcutaneous nivolumab demonstrated noninferiority to IV nivolumab in the key powered secondary end point of objective response rate (ORR). Specifically, the subcutaneous arm demonstrated an ORR of 24.2% (95% CI, 19.0-30.0) per blinded independent central review (BICR), compared with 18.2% (95% CI, 13.6-23.6) in the IV arm.

The safety profile for subcutaneous nivolumab was consistent with that of the IV formulation. Among patients who received the subcutaneous formulation, 8.1% experienced injection-site reactions, with all being low-grade and transient. Deaths due to study drug toxicity occurred in 3 patients in the subcutaneous arm and 1 patient in the IV arm. Most deaths that occurred during the study were due to disease progression.

In total, the phase 3, open-label CheckMate-67T trial enrolled 495 patients with advanced or metastatic ccRCC who had received prior systemic therapy. Patients were randomly assigned 1:1 to receive 1200 mg subcutaneous nivolumab plus rHuPH20 every 4 weeks (n = 248) or to 3 mg/kg IV nivolumab every 2 weeks (n = 247) for up to 2 years of treatment or until disease progression, unacceptable toxicity, withdrawal, or death.

The co-primary pharmacokinetic end points for noninferiority testing were C

 of subcutaneous nivolumab vs IV nivolumab. The key secondary end point was ORR per BICR.

Final completion of the CheckMate-67T study is expected in January 2026.

1. U.S. Food and Drug Administration accepts Bristol Myers Squibb’s application for subcutaneous nivolumab (nivolumab and hyaluronidase). News release. Bristol Myers Squibb. May 6, 2024. Accessed May 7, 2024. https://news.bms.com/news/corporate-financial/2024/U.S.-Food-and-Drug-Administration-Accepts-Bristol-Myers-Squibbs-Application-for-Subcutaneous-Nivolumab-nivolumab-and-hyaluronidase/default.aspx

2. Bristol Myers Squibb announces updated action date by the U.S. Food and Drug Administration for subcutaneous nivolumab (nivolumab and hyaluronidase). News release. Published online and accessed May 21, 2024. https://investors.bms.com/iframes/press-releases/press-release-details/2024/Bristol-Myers-Squibb-Announces-Updated-Action-Date-by-the-U.S.-Food-and-Drug-Administration-for-Subcutaneous-Nivolumab-nivolumab-and-hyaluronidase/default.aspx

3. George S, Bourlon TB, Chacon MR, et al. Subcutaneous nivolumab (NIVO SC) vs intravenous nivolumab (NIVO IV) in patients with previously treated advanced or metastatic clear cell renal cell carcinoma (ccRCC): Pharmacokinetics (PK), efficacy, and safety results from CheckMate 67T. 

4. A study of subcutaneous nivolumab versus intravenous nivolumab in participants with previously treated clear cell renal cell carcinoma that is advanced or has spread (CheckMate-67T). ClinicalTrials.gov. Last updated March 1, 2024. Accessed May 7, 2024. https://clinicaltrials.gov/study/NCT04810078

The FDA is set to have a decision regarding the subcutaneous nivolumab formulation on or by December 29, 2024. 

FDA accepts BLA for subcutaneous nivolumab in solid tumors

A 35-year-old male from Sudan was hospitalized with a right obstructing 1-cm ureteral stone seen on KUB. The KUB also revealed curvilinear calcification in the bladder wall. The patient was taken to the operating room for ureteroscopy and laser lithotripsy.

During cystoscopy, a rim of calcification was seen along the right ureteric ridge (figure 1a). A biopsy of this area was taken with the pathology shown in figure 1b.

B. Squamous cell carcinoma of the bladder

A 35-year-old male from Sudan presented with a 1-cm obstructing ureteral stone and curvilinear calcification in the bladder wall, as seen on KUB imaging. The patient underwent ureteroscopy and laser lithotripsy. During cystoscopy, calcification was observed along the right ureteric ridge. A biopsy was performed on this area to further investigate the pathology. The findings from the biopsy are crucial for understanding the underlying condition contributing to the calcification and obstruction, which may have implications for the patient's treatment and management.

A 35-year-old male from Sudan was hospitalized with a right obstructing 1-cm ureteral stone seen on KUB. The KUB also revealed curvilinear calcification in the bladder wall. The patient was taken to the operating room for ureteroscopy and laser lithotripsy. During cystoscopy, a rim of calcification was seen along the right ureteric ridge. What is the diagnosis?

Residents Corner

Quiz: Sandy patch on cystoscopy

a urologist with Atlantic Urology Specialists in South Carolina, outlines his approach to evaluating candidates for testosterone replacement therapy (TRT). He emphasizes that although lab values are important, his primary focus is on a patient’s symptoms. Many men with low testosterone may feel fine and not require treatment, whereas others with symptoms such as fatigue, depression, sexual dysfunction, and low motivation may benefit from therapy. Jansen begins by taking a comprehensive medical history to identify other conditions or medications that might affect testosterone levels. He ensures low testosterone is documented, and if levels are borderline or normal but symptoms persist, he checks free testosterone. Additional labs include a pituitary panel (FSH, LH, prolactin), vitamin D, and fasting insulin for those at risk for prediabetes. This information guides a personalized treatment plan.

Jansen outlines his approach to evaluating candidates for testosterone replacement therapy

Robert Jansen, MD, discusses evaluation of candidates for testosterone therapy

Jansen also addresses common misconceptions about TRT. He stresses that testosterone is not a cure-all and often requires adjunct evaluation and management of other conditions such as sleep apnea or thyroid disorders. Erectile dysfunction, for instance, may not resolve with TRT alone and may need separate treatment. He educates patients that without lifestyle changes, TRT may not be effective long-term. Some patients also fear TRT may cause cancer or heart problems. Jansen reassures them, citing literature showing no link to increased cancer risk—especially prostate cancer—and that cardiovascular risks are minimal or even questionable. Overall, patient counseling, symptom assessment, and a comprehensive evaluation are key to successful TRT management.

Jansen stresses that testosterone is not a cure-all and often requires adjunct evaluation and management of other conditions such as sleep apnea or thyroid disorders. 

Administration of mitomycin for intravesical solution (Zusduri, formerly UGN-102) in the home setting was found to be a feasible, safe, and effective method for treating patients with recurrent low-grade, intermediate-risk non–muscle invasive bladder cancer (LG-IR-NMIBC), according to data from the phase 3b BL010 study (NCT05136898) published in 

Mitomycin intravesical instillation was granted FDA approval in June 2025 for recurrent LG-IR-NMIBC. The therapy is currently administered in an outpatient clinical setting.

“The ability to deliver this treatment safely and effectively at home has the potential to ease the burden on patients and reduce reliance on hospital or clinic resources,” explained lead author David Morris, MD, who is a practicing urologist at Urology Associates, PC, in Nashville, Tennessee, in a news release on the findings.

 “As physicians, we’re always looking for ways to provide effective care with greater comfort and convenience. These findings represent an important step in that direction.”

Overall, 75% of patients (6 of 8) completed all 6 scheduled treatments. Five of those patients reported that they would recommend home instillation of mitomycin intravesical solution to other patients with NMIBC.

The study also included investigator end-of-study questionnaires. In total, 4 investigators participated in the study. Investigators reported that home instillation was “not different” than office instillation for 62.5% of patients (6 of 8). Further, home health professionals (HHPs) reported that they were comfortable administering the therapy, did not have difficulty or concerns administering the instillation, and had sufficient support to provide the instillation within the home setting for 91.9% of the instillations (34 of 37).

In total, 75% of patients (6 of 8) achieved the study’s secondary end point of a complete response at 3 months.

According to the authors, the safety profile for mitomycin intravesical solution was “consistent with previous studies and primarily characterized by mild to moderate urinary symptoms.”

All patients experienced at least 1 treatment-emergent adverse event (TEAE), with the majority being mild to moderate in severity and resolved or resolving, the authors noted. Treatment-related TEAEs were reported in 50% (4 of 8) of patients and included dysuria and fatigue. Three procedure-related TEAEs were reported in 1 patient, which included hematuria, micturition urgency, and pollakiuria.

Further, 3 patients (37.5%) experienced at least 1 serious TEAE. Nontreatment-related AEs led to study discontinuation in 2 patients (25%).

In total, the single-arm, open-label phase 3b BL010 trial enrolled 8 adult patients with recurrent LG-IR-NMIBC through 5 clinical trial sites across the US.

To be eligible for enrollment, patients needed to have histologically confirmed recurrent LG-IR-NMIBC by cold-cup biopsy, intermediate risk disease, adequate organ and bone marrow function, and negative voiding cytology for high-grade disease within 6 weeks of the screening visit. Participants also needed to have no evidence of an active urinary tract infection and a life expectancy of at least the duration of the study.

For the study, patients received 1 instillation of mitomycin intravesical solution at the investigative site, followed by 5 subsequent instillations performed in the home setting by an HHP. The study’s primary end point was feasibility of home instillation, and the secondary end point was 3-month complete response rate, determined via cystoscopy, urine cytology, and for-cause biopsy.

“This patient-centered approach to care reflects our commitment to redefining how urologic cancers are treated, offering patients access to effective and convenient treatment options,” concluded Mark Schoenberg, MD, chief medical officer of UroGen, in the news release.

 “The ability to potentially administer Zusduri safely in the home represents a meaningful advancement for patients and caregivers alike, especially those who may face challenges traveling to frequent clinic visits.”

1. Morris D, Kramolowsky II, EV, Bivins VM, et al. Home instillation of UGN-102 for primary chemoablation of recurrent low-grade intermediate-risk non-muscle-invasive bladder cancer: a single-arm, open-label, phase 3b trial. 

. 2025;43(3). doi:10.1016/j.urolonc.2024.12.127

2. UroGen announces publication of phase 3b study results demonstrating the feasibility of home instillation of ZUSDURI for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer in Reviews in Urology. News release. UroGen Pharma Ltd. July 28, 2025. Accessed July 28, 2025. https://investors.urogen.com/news-releases/news-release-details/urogen-announces-publication-phase-3b-study-results

3. Feasibility of home instillation of UGN-102 for treatment of low-grade (LG) non-muscle invasive bladder cancer (NMIBC). ClinicalTrials.gov. Last updated September 19, 2024. Accessed July 28, 2025. https://clinicaltrials.gov/study/NCT05136898

The administration of mitomycin for intravesical solution in a home setting has been shown to be feasible, safe, and effective for treating recurrent low-grade, intermediate-risk non–muscle invasive bladder cancer. The phase 3b BL010 study demonstrated that home treatment could ease patient burden and reduce reliance on clinical resources. Most patients completed the treatment, with a significant portion achieving a complete response. The safety profile was consistent with previous studies, with mild to moderate adverse events. This approach offers a patient-centered, convenient treatment option.

Data from the phase 3b study were recently published in Reviews in Urology, showing that administration of mitomycin intravesical solution in the home setting was feasible, safe, and effective. 

Stephen A. Boorjian, MD

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