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

The results from the SABRE trial are intended to support the design of a registrational trial of 64Cu-SAR-Bombesin. 

64Cu-SAR-Bombesin shows efficacy in detecting prostate cancer recurrence

Benjamin M. Brucker, MD, discusses best practices for the onabotulinumtoxinA procedure, spanning all phases of treatment—before, during, and after administration.

From prep to follow-up: Key considerations for administering onabotulinumtoxinA

The approval is supported by findings from the phase 3 ENVISION trial.

FDA approves mitomycin intravesical solution for recurrent LG-IR-NMIBC

"I'm excited to see how these models are going to continue to be developed and applied in clinical practice, because precision medicine is here, and I’m looking forward to it," says Madhur Nayan, MD, PhD.

AI-based tool aims to optimize MRI use in prostate cancer diagnosis

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"At ASCO GU, we presented the final analysis of the study, which confirmed the superiority of a combination over the TKI monotherapy in terms of both progression-free survival as well as overall survival," says Camillo Porta, MD. 

Camillo Porta, MD, offers key takeaways from CheckMate 9ER trial in renal cell carcinoma

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 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?

Video Series

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 recently published paper sought to outline best practices in the treatment of overactive bladder (OAB) using onabotulinumtoxinA (onabotA, Botox).

,study author Karyn S. Eilber, MD, emphasized the critical role of the procedure room environment and follow-up protocols in optimizing patient comfort and adherence to overactive bladder (OAB) management with onabotulinumtoxinA (Botox) injections.

To enhance patient experience and encourage return visits, Eilber's office implements several strategies. These include using aromatherapy machines with soft lights instead of harsh fluorescent lighting and offering background noise options. They provide cloth gowns for comfort and encourage patients to wear warm clothing. The presence of consistent staff and the use of "verbal anesthesia" also contribute significantly to a more positive experience, even when the procedure itself might be physically uncomfortable.

Karyn S. Eilber, MD, emphasized the critical role of the procedure room environment and follow-up protocols in optimizing patient comfort and adherence to overactive bladder (OAB) management with onabotulinumtoxinA (Botox) injections.

OnabotA for OAB: Enhancing comfort and ensuring adherence

Regarding follow-up, Eilber's protocol involves a 2-week post-injection check-up to assess residual urine and the efficacy of the onabotA. Subsequent injections are typically scheduled at 6-month intervals, aligning with the average duration of effect. However, patients are advised to adjust this schedule based on their individual response, ranging from 5-month intervals if the effect wears off sooner, to potentially 7 or 8 months if the benefits last longer. The importance of proactively scheduling the next appointment was highlighted to prevent lapses in treatment, ensuring ongoing therapy and reducing logistical barriers for both patients and the practice.

1. Eilber KS, Brucker BM, Pezzella A, Lucente V, Benson K, Kennelly MJ. Expert opinions on best practices for overactive bladder management with onabotulinumtoxinA. 

 2025;17(4):207. doi:10.3390/toxins17040207

Karyn S. Eilber, MD,'s follow-up protocol involves a 2-week post-injection check-up to assess residual urine and the efficacy of the onabotA

Paclitaxel eluting bioabsorbable implants demonstrated encouraging efficacy and appeared to be safe and feasible in the management of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH), according to 6-month data from a phase 1 first-in-human study (NCT06136819).

The bioabsorbable implants are a novel office-based, minimally invasive form of intraprostatic drug elution (IPDE) therapy. Findings on this investigational therapy were presented at the 

American Urological Association (AUA) 2025 Annual Meeting

"In the US alone, an estimated 40 million men are affected by BPH, with 8 million currently on daily medications—many of whom are unsatisfied with current treatment options," said Shahram Gholami, MD, cofounder of Resurge Therapeutics, in a news release from the company.

 "Our early clinical results suggest the novel IPDE therapy has the potential to offer durable symptom relief in a single treatment, without the [adverse] effects of either oral drugs or surgical procedures and also without the adherence challenges of daily medications.

At the time of data report, the study had dosed 5 patients with a single administration of initial IPDE via transperineal implantation, with each patient receiving 4 to 6 bioabsorbable implants during the procedure. The mean age of participants was 63 years.

Data showed that posttreatment pain levels were minimal, with a score via visual analogue scale of 0.9 at 1 day following the procedure and 0.0 at 7 days following the procedure. At discharge, pain levels were also 0.0. There were no instances of postprocedure catheterization.

Treatment also demonstrated promising efficacy, with 80% of patients showing an improvement in symptoms. Data showed an 11-point decrease in International Prostate Symptom Score (IPSS) from baseline to 90 days following treatment. Additionally, there was an average improvement of 5 mL/sec in the maximum urinary flow rate.

There have been no serious drug- or procedure-related adverse events (AEs) reported to date. Observed AEs were generally mild and resolved within 7 days or less from treatment, according to the authors.

In total, the phase 1 dose escalation trial plans to enroll 20 patients across 4 clinical trial sites in Australia and New Zealand.

To be eligible for enrollment, patients need to be aged 50 years or older and have an IPSS of at least 13, a peak urine flow rate between 5 mL/sec and 15 mL/sec, a voided volume of at least 100 mL, a postvoid residual urine volume of at least 250 mL, a prostate volume between 25 cc and 100 cc, and an inadequate response and/or refusal of medical therapy for LUTS.

The primary outcome measure is the absence of unanticipated AEs or serious AEs, measured from baseline to day 180. Secondary outcome measures include the change in prostate volume, change in IPSS, postvoid residual, peak flow rate, average flow rate, and voided volume, all measured through 180 days.

Overall, the phase 1 study is ongoing, with final completion expected in June 2025.

The authors noted, “Further follow-up to 180 days and additional treatments at current and higher doses are ongoing in the first 20 patients.”

Resurge Therapeutics also announced plans to collaborate with the FDA to advance the IPDE therapy through further clinical studies and ultimately to market approval.

1. Vermeulen LP, Ordones FV, Gilling PJ, et al. A first in human safety and feasibility study of intraprostatic drug eluting bioabsorbable implants for treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia. 

. 2025;213(5S):e987. doi:10.1097/01.JU.0001110064.72214.9d.10

2. Resurge Therapeutics announces compelling six-month clinical results from novel prostate drug delivery therapy. News release. Resurge Therapeutics. May 27, 2025. Accessed May 29, 2025. https://www.prnewswire.com/news-releases/resurge-therapeutics-announces-compelling-six-month-clinical-results-from-novel-prostate-drug-delivery-therapy-302464645.html

3. RT-310 dose escalation BPH study. ClinicalTrials.gov. Last updated November 13, 2024. Accessed May 29, 2025. https://clinicaltrials.gov/study/NCT06136819

Paclitaxel eluting bioabsorbable implants show promising results in managing lower urinary tract symptoms due to benign prostatic hyperplasia, based on a phase 1 study. This novel intraprostatic drug elution therapy offers a minimally invasive, office-based treatment option, potentially providing durable symptom relief without the side effects of oral drugs or surgery. Initial data from five patients indicate minimal post-treatment pain and significant symptom improvement, with no serious adverse events reported. The ongoing trial aims to enroll 20 patients, with completion expected by June 2025.

Further follow-up and additional treatments in the study are ongoing. 

Intraprostatic drug elution therapy shows promise for BPH-related LUTS

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?

Camillo Porta, MD

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