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

The target action date for the application is December 11, 2025.

FDA grants priority review to gepotidacin for uncomplicated urogenital gonorrhea

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In these videos, expert surgeons demonstrate robot-assisted penile inversion vaginoplasty, single-stage metoidioplasty, and simple orchiectomy for transgender patients.

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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

Updated data from the phase 3 ENVISION trial (NCT05243550) point to sustained efficacy of mitomycin for intravesical solution (Zusduri; formerly UGN-102) in patients with recurrent low-grade, intermediate-risk non–muscle invasive bladder cancer (LG-IR-NMIBC). Specifically, treatment with mitomycin intravesical solution led to a 24-month duration of response (DOR) of 72.2% (95% CI, 64.1 to 78.8) among patients who achieved an initial complete response to treatment at 3-month follow-up, UroGen reported in a news release.

Mitomycin for intravesical solution was granted FDA approval in June 2025 for adult patients with recurrent LG-IR-NMIBC based on initial data from the ENVISION trial.

“This latest update from the pivotal ENVISION trial of ZUSDURI showed that, among patients who achieved a complete response at 3 months, the probability of remaining event-free 24 months after CR was 72.2%,” said principal investigator Sandip Prasad, MD, MPhil, director of genitourinary surgical oncology and vice chair of urology at Morristown Medical Center/Atlantic Health System, NJ, in the news release.

 “Among patients who achieved a complete response, the event rate over time has remained stable. This DOR result highlights the sustained efficacy of the therapy and reinforces its potential as a durable treatment option.”

The median follow-up time after a 3-month CR in the current analysis was 23.7 months. At the time of data report, the median DOR has not been reached.

The most common adverse events (AEs) in the trial included dysuria, increased potassium, increased creatinine, decreased hemoglobin, increased eosinophils, increased aspartate aminotransferase, increased alanine aminotransferase, decreased lymphocytes, urinary tract infection, decreased neutrophils, and hematuria. According to UroGen, AEs were generally mild to moderate in severity.

Serious AEs were reported in 12% of patients and included urinary retention (0.8%) and urethral stenosis (0.4%).

The ENVISION trial initially met its primary end point by demonstrating a 78% (95% CI, 72 to 83) complete response rate in patients with LG-IR-NMIBC at 3 months following the first instillation of the therapy.

 Overall, 79% of responders remained in CR at 12 months.

Data presented at the 2025 American Society of Clinical Oncology Annual Meeting in Chicago, Illinois,

 additionally showed an 18-month CR rate of 80.6% (95% CI, 74.0 to 85.7).

Overall, the single-arm, multinational ENVISION trial evaluated the safety and efficacy of mitomycin as a primary chemoablative therapy in patients with LG-IR-NMIBC. In total, the study enrolled 240 adult patients across 56 sites in the US and Europe.

Patients were eligible for enrollment in the trial if they had a negative voiding cytology for high-grade disease within 8 weeks before screening, adequate organ and bone marrow function, and an anticipated life expectancy of at least the duration of the trial.

 Those included in the study received 6 once-weekly intravesical instillations of mitomycin.

The primary end point for the study was the complete response rate at 3 months following the first instillation of the therapy. Secondary outcome measures included DOR, durable complete response rate, disease-free survival, and safety.

“For the first time, adult patients with recurrent LG-IR-NMIBC have an FDA-approved therapy,” Prasad added in the news release.

 “This marks a potentially transformative step forward in how we manage this chronic, highly recurrent, and disruptive cancer. ZUSDURI is a new, outpatient treatment option for patients that can help provide a clinically meaningful recurrence-free interval, which is compelling given the highly recurrent nature of LG-IR-NMIBC.”

The ENVISION trial is ongoing to assess the long-term safety and efficacy of mitomycin for intravesical solution as part of a post-marketing commitment with the FDA, UroGen previously reported.

1. UroGen announces 24-month duration of response of 72.2% from the pivotal phase 3 ENVISION trial of ZUSDURI, the first and only FDA-approved medicine for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer. News release. UroGen Pharma, Ltd. August 5, 2025. Accessed August 5, 2025. https://investors.urogen.com/news-releases/news-release-details/urogen-announces-24-month-duration-response-722-pivotal-phase-3

2. FDA approves mitomycin intravesical solution for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer. News release. US Food & Drug Administration. June 12, 2025. Accessed August 5, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mitomycin-intravesical-solution-recurrent-low-grade-intermediate-risk-non-muscle

3. U.S. FDA approves UroGen’s ZUSDURI (mitomycin) for intravesical solution as the first and only medication for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). News release. UroGen Pharma, Ltd. June 12, 2025. Accessed August 5, 2025. https://investors.urogen.com/news-releases/news-release-details/us-fda-approves-urogens-zusduritm-mitomycin-intravesical

4. Prasad SM, Mihaylov NV, Khuskivadze A, et al. Duration of response (DoR) following treatment with UGN-102 in patients with recurrent, low-grade, intermediate-risk, non-muscle invasive, bladder cancer: 18-month DoR data from the phase 3 ENVISION trial. 

. 2025;43 (suppl 16). https://doi.org/10.1200/JCO.2025.43.16_suppl.4598

5. A phase 3 single-arm study of UGN-102 for treatment of low grade intermediate risk non-muscle-invasive bladder cancer (ENVISION). ClinicalTrials.gov. Last updated November 4, 2024. Accessed August 5, 2025. https://clinicaltrials.gov/study/NCT05243550

Updated data from the phase 3 ENVISION trial demonstrate the sustained efficacy of mitomycin for intravesical solution (ZUSDURI) in patients with recurrent low-grade, intermediate-risk non–muscle invasive bladder cancer (LG-IR-NMIBC). The treatment achieved a 24-month duration of response (DOR) of 72.2% among patients with an initial complete response at 3 months. The trial also reported a 78% complete response rate at 3 months and an 80.6% rate at 18 months. Adverse events were generally mild to moderate, with serious events in 12% of patients.

Treatment with mitomycin for intravesical solution led to a 24-month DOR of 72.2% among patients who achieved an initial complete response. 

Updated ENVISION data show sustained efficacy of mitomycin intravesical solution for LG-IR-NMIBC

1:56-4:02 - Importance of trial design in therapy selection

4:02-8:09 - Benefits of cooperative trials and comparison of trial end points

8:09-12:10 - Applicability of trial inclusion criteria in daily practice

12:10-13:17 - Moving away from ADT monotherapy as a comparator and applicability of subset analysis

13:17-16:08 - Evaluating the relevance of a clinical trial

16:08-18:59 - Translating statistical significance, biomarker analysis, and subgroup analysis to the clinic

18:59-22:34 - Use of rPFS in informing clinical decisions

22:34-26:56 - Evaluation of patients with conventional imaging and PSMA PET

26:56-31:14 - Importance of quality of life data in clinical trials

31:14-34:34 - Importance of trial design in evaluating a therapy

34:34-37:22 - Patient selection for triplet therapy

Jack Andrews, MD; Alicia Morgans, MD, MPH; and Ashley Ross MD, PhD, discuss how trial design, inclusion criteria, and end points like radiographic progression-free survival vs overall survival impact clinical decision-making in prostate cancer treatment, emphasizing the importance of quality of life data and the shift from using ADT alone as standard care toward combination therapies in prostate cancer management.

Exploring Recent Developments in the Treatment of Prostate Cancer

Key considerations and limitations of clinical trial data

The question of how to interpret and compare clinical trial data in bladder cancer treatment is crucial and complex. Different trials often have widely varying methodologies, which makes broad generalizations challenging. Many studies in this space are single-arm trials without direct comparison groups, limiting how well their results can be applied to everyday clinical practice. Understanding the details of each trial’s design is essential before drawing conclusions about efficacy or making treatment decisions based on those data.

One major factor influencing trial outcomes is how treatment failure is defined and managed. Older studies often considered failure immediately after induction therapy as grounds to stop treatment, but contemporary clinical practice tends to be more flexible. Many patients with early signs of recurrence, but without disease progression, are given additional rounds of treatment—known as reinduction. Some trials allow for reinduction, whereas others do not, which can greatly affect response rates and overall interpretation of success. Additionally, methods for detecting recurrence vary, including the use of cystoscopy, cytology, and enhanced imaging techniques like blue light cystoscopy, adding further variability to trial results.

These differences between trial protocols and real-world practice are especially important for providers working in community settings, where access to advanced diagnostic tools and treatment options may be limited. As a result, patients seen in everyday practice often differ from those enrolled in clinical trials, further complicating the direct application of trial data. The takeaway is to carefully evaluate trial methodologies and remain cautious about directly comparing results or generalizing findings without considering these nuances.

An expert would summarize that interpreting bladder cancer clinical trial data requires careful consideration of varying trial designs, definitions of treatment failure, and diagnostic methods, as differences from real-world practice can limit the direct applicability and comparison of results.

Thomas J. Walsh, MD

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