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

However, M-HoLEP was superior in terms of enucleation time and efficiency, catheterization time, and hospital stay.

ThuFLEP and M-HoLEP achieve comparable functional outcomes in BPH

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. 

Home instillation of mitomycin intravesical solution found feasible, safe in NMIBC

Data showed that fracture risk rises briefly after menopausal hormone therapy discontinuation, then falls below never-users. 

Study shows persistent bone protective effect of menopausal hormone therapy  

MRWS was shown to prolong the time off systemic therapy and was associated with favorable tolerability. 

Metastasis-directed radiotherapy without systemic therapy yields promising outcomes in oligometastatic ccRCC

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Paul F. Schellhammer, MD, a member of the Urology Times editorial council, is professor of urology and program director of the Virginia Prostate Center of the Eastern Virginia Medical School and Sentara Cancer Institute, Norfolk.

Progression-free curves for N0 disease were improved when more than eight to 10 nodes per side were removed.

Bladder cancer studies help pinpoint risk of recurrence

I believe the evidence is accumulating in favor of earlier [androgen deprivation] therapy to provide a survival benefit.

Data shed light on salvage RT, immediate hormone Tx

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

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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

The ADVANCED-2 trial, TARA-002

TARA-002 is a novel therapeutic agent currently being investigated for the treatment of non–muscle-invasive bladder cancer. It was evaluated in a phase 2 open-label clinical trial, where the agent—a lyophilized preparation of 

—was delivered directly into the bladder through a catheter. The treatment concept mirrors that of BCG therapy, aiming to stimulate a local immune response within the bladder. Patients followed a regimen similar to BCG, receiving weekly doses over 6 weeks, with options for reinduction or maintenance based on individual response.

The trial involved 2 groups of patients: those who had never received BCG therapy (BCG naive) and those whose disease had not responded to it (BCG unresponsive). The BCG-naive group has completed enrollment, while the BCG-unresponsive cohort is still being enrolled. Early results from the trial are promising, especially in the difficult-to-treat BCG-unresponsive population, where high response rates were observed. The BCG-naive arm also demonstrated favorable outcomes, further supporting the potential of TARA-002 as an effective option.

This study holds particular significance given the current limitations in bladder cancer treatment. BCG shortages and varied patient responses to it have highlighted the need for alternative therapies. TARA-002 contributes to a growing arsenal of immunotherapy-based treatments that may offer more individualized and effective care. Expanding the range of available options is crucial not only for managing the disease more effectively but also for adapting to changing treatment landscapes and patient needs. This trial represents a valuable step toward broadening the therapeutic toolkit for bladder cancer.

An expert summarizes that TARA-002, a novel immunotherapy derived from Streptococcus pyogenes, is showing promising results in a phase 2 trial for non–muscle-invasive bladder cancer—particularly in BCG-unresponsive patients—and may offer a much-needed alternative amid current treatment limitations and BCG shortages.

Investigator Perspectives

Unmet needs in high risk NMIBC

Bladder cancer is a challenging and recurrent disease that significantly impacts both those experiencing it and those providing care. Its management demands ongoing surveillance and frequent interventions, making it particularly challenging for patients. When the cancer penetrates the deeper muscle layers of the bladder, the risk of it spreading beyond the bladder increases dramatically, heightening the threat of severe outcomes, including death. For this reason, a timely and structured therapeutic approach is essential—especially for those with high-risk, non–muscle-invasive forms of the disease.

In cases where the disease becomes unresponsive to BCG therapy, treatment becomes even more complex. Patients in this category have typically undergone multiple rounds of intravesical therapy without success. Historically, the standard response was surgical removal of the bladder to prevent further progression and metastasis. However, emerging therapies have shown promise in controlling tumor growth even after BCG failure, offering new hope and potentially changing the course of treatment for this difficult condition.

Surgical removal of the bladder, known as radical cystectomy, remains a highly invasive and risky procedure. Despite being performed at experienced centers, it carries a 30% to 50% complication rate, notable readmission rates, and a perioperative mortality risk of approximately 2%. Moreover, it has a lasting psychological and quality-of-life impact on patients. With the development of newer, more effective therapies, there is increasing potential to delay or avoid this operation in select patients. While surgery is still necessary in some cases, current trends suggest a shift toward managing the disease less invasively for as long as possible.

An expert summarizes that bladder cancer management is evolving from traditional radical surgery toward more personalized, less invasive approaches—highlighting promising therapies like TARA-002 that activate broad immune responses, address both BCG-unresponsive and BCG-naive patients amid shortages, and offer familiar, manageable administration—while underscoring the critical need to carefully interpret diverse clinical trial data, optimize treatment sequencing and combinations, and integrate advanced diagnostics to improve outcomes, preserve bladder function, and reduce overtreatment in this complex disease landscape.

The FDA recently expanded the label for the Rezūm System, which now includes prostate volumes up to 150 cm

 emphasizes that beyond prostate volume, several patient-specific factors are critical when assessing candidacy for Rezūm Water Vapor Therapy. A key element he considers is the patient’s motivation and expectations. McVary highlights the importance of ensuring patients have realistic goals, as some may expect life-changing outcomes that are not supported by clinical evidence. He stresses the need to clearly communicate the benefits—such as quicker recovery, rapid symptom relief, preservation of sexual function, and reduced anesthesia requirements—while also setting appropriate boundaries about what Rezūm can and cannot achieve.

McVary also considers a patient’s overall health status, especially if they are medically complex or require anticoagulation therapy due to heart conditions or stents. Such factors may affect procedural safety and outcomes, and should be factored into the decision-making process.

Kevin T. McVary, MD, FACS, emphasizes that beyond prostate volume, several patient-specific factors are critical when assessing candidacy for Rezūm Water Vapor Thermal Therapy

Expert discusses setting realistic expectations for Rezum for BPH

Another consideration is the setting in which the procedure is performed. McVary notes that 95% of his Rezūm procedures are performed in-office, reflecting his experience and comfort level from participating as principal investigator in the pivotal trial. However, he acknowledges that less experienced urologists may prefer to begin in ambulatory surgery centers for greater support and lower pressure during initial procedures.

Finally, McVary cautions patients to understand the limitations of existing data. Although 5-year outcome data are promising, long-term effects beyond that timeframe remain unknown. Overall, McVary advocates for a comprehensive and individualized approach, considering the patient’s physical health, expectations, procedural setting, and candid communication to determine whether Rezūm is the right treatment choice.

One consideration is the setting in which the procedure is performed. 

Paul F. Schellhammer, MD

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