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

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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

Video content above is prompted by the following:

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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 BCG shortage, which ramped up in 2019,

 has significantly disrupted the treatment landscape for patients with non–muscle invasive bladder cancer (NMIBC), a disease for which BCG has been the standard of care for decades. To meet this challenge, researchers, industry partners, and other clinical experts have worked together to accelerate the development of alternative therapies that offer patients options beyond BCG.

®, Anne K. Schuckman, MD, described this moment as a “renaissance” in NMIBC care. With 3 FDA approvals since 2020 and many more agents in development, urologists and patients now have a wealth of therapeutic options. This innovation is transforming how clinicians approach the management of high-risk disease, with increasing emphasis on bladder preservation and personalized treatment strategies.

Thus, with an expanding arsenal of novel therapies, urologists now face different challenges: selecting the most appropriate treatment for each patient, navigating optimal sequencing strategies, and determining which combinations may provide added benefit.

One thing is clear: We are just on the cusp of a paradigm shift in NMIBC care. These advances are not only offering patients the chance to delay or avoid radical surgery, but offer the potential for years of effective, bladder-preserving treatment. With even more therapies in the pipeline, the future holds promise for more personalized, durable, and quality-of-life–preserving approaches to care.

Schuckman is an associate professor of urology at the University of Southern California, Los Angeles.

 In your view, how has the BCG shortage accelerated the adoption of novel alternative therapies such as gene therapy or checkpoint inhibitors?

 When the BCG shortage started, I don't think a lot of people, even at that time, were thinking that there would be a lot of trials in the BCG-naive space. I remember being in meetings with bladder cancer experts and people saying "It'd be too hard to do those trials. They'll never happen." Now, we have many trials where we have patients who are BCG-naive being treated with novel agents based on obviously preliminary data from the BCG-refractory space. To me, the shortage in BCG has really opened people's minds and scientific creativity to moving other therapies first, getting rid of the old paradigm, and saying, “Why is BCG the only thing that we're thinking about in these patients?” I think it's sparked a whole new era in how we're thinking about what the best first-line treatment for patients might be.

: As you alluded to, there has been an explosion of new options in NMIBC, with even more agents coming down the pike. From your experience, what are patients looking for when they're choosing between these different options?

 The answer is probably a little bit different for all patients. The bottom line is patients are looking for a therapy that is effective. For some people, that means long-term efficacy, and for [others] that means just buying a few years before they may need to move on to some other type of therapy. So, number 1, efficacy.

I think number 2, patients are looking for something that's going to be fairly easy to tolerate and not disrupt their life very much while they're undergoing therapy. That might mean less treatments, [or] it might mean that it's oral or easy to have administered. And 3, obviously, I think the least [adverse events] that patients experience, the better.

What are some of the biggest challenges right now for you in terms of delivering optimal bladder cancer care?

 From a patient perspective, one of the challenges right now, honestly, is that there are so many different options. If you go to one place, you're going to be offered this. If you go to another place, you're going to be offered this. Sorting through what might be the best option is tricky. I think you need to make sure that you are talking with somebody who has a few things at their fingertips so that they can help pick what might be best for an individual patient.

I think one of the big challenges right now for NMIBC providers is that we don't know the optimal sequencing for any of these agents. [There are a number of] interesting trials that are ongoing right now, and we're learning about multiple things. One, what agents can we use first? What agents should we use second? As we go forward, I think we'll learn a lot about [how these should be sequenced. We might know that a therapy works,] but does it work after somebody's had a PD-1 agent, or would it be better if they got the PD-1 agent with that? There are certainly ongoing trials right now looking at pairing systemic PD agents with intravesical therapies to try to increase immune response in that way. We've seen all these single-arm trials in a single agent, and as we start to see some of these combination agents, that'll be really interesting.

What role do you see for gene therapy in the treatment landscape moving forward?

 We're probably on the very early application of gene therapy in non–muscle invasive bladder cancer. We only have 1 approved, but we have enGene’s trial ongoing right now, which is a non-viral vector gene therapy product. I think people will start to develop more novel ways to incorporate this. As gene therapy goes forward, practitioners and patients will become more comfortable and fluid in discussing those therapies. It will become 1 part of the arsenal of how we're caring for NMIBC in the future.

Is there anything else that you wanted to add?

 It's exciting to be part of this time, which I feel like is a total renaissance in the care of patients with non–muscle invasive bladder cancer, particularly for patients with really high-risk disease. Even in just the past 3 years, this disease has gone from something where we can put off more aggressive therapy for a year, to something where we're talking about having, potentially, for some patients, years and years of sequencing therapies and allowing them to maintain their bladders. I think most patients want to do [that. These options] allow us to avoid having to do such a radical surgery in somebody with non–muscle invasive disease. It's an exciting time for investigators and an even more exciting time for patients. The science is just unbelievable, novel, and exciting.

1. CBER-regulated products: Current shortages. US Food & Drug Administration. Accessed June 16, 2025. https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/cber-regulated-products-current-shortages

The BCG shortage has catalyzed a significant shift in the treatment of non–muscle invasive bladder cancer (NMIBC), leading to the development and approval of alternative therapies. This has resulted in a "renaissance" in NMIBC care, with a focus on bladder preservation and personalized treatment strategies. Urologists now face challenges in selecting appropriate treatments and sequencing strategies. Gene therapy and checkpoint inhibitors are emerging as promising options. The future of NMIBC treatment is promising, with ongoing trials and the potential for more personalized, durable, and quality-of-life–preserving approaches.

Anne K. Schuckman, MD, describes the growing number of options in NMIBC and the impact of these therapies on clinical practice.

From BCG shortage to scientific surge: Inside the NMIBC treatment renaissance

There has been an explosion of treatment options in non–muscle invasive bladder cancer (NMIBC) in recent years, with even more coming down the pike. Many of these agents have demonstrated encouraging efficacy and manageable safety in clinical trials, meaning that patients and urologists must consider other factors when choosing between options.

, explains, this is a good challenge to have. The wealth of options will allow urologists to tailor treatment to both the individual’s preferences and, as we learn more, hopefully the patient’s specific disease characteristics.

He notes, “At the end of the day, it's going to be unlikely that we're going to use a single therapy for all of our patients. I think precision medicine is going to become more widespread as we understand who is going to respond best to which treatment, so I'm really excited to develop biomarkers that might help us guide us to what the best therapy is for each specific patient.”

Packiam is an associate professor of surgery at Rutgers Robert Wood Johnson Medical School as well as the director of clinical and translational research in urologic oncology at Rutgers Cancer Institute in New Jersey.

Vignesh Packiam, MD, outlines key considerations for choosing between options in NMIBC.

Vignesh Packiam, MD, on choosing between options in NMIBC

Specifically, Packiam says that long-term bladder symptoms associated with treatment, in addition to the short-term tolerability data, will be important for patients to understand as we gather more data.

“I think each therapy is going to have its own unique profile with how it affects the bladder in the long-term,” he stated.

Packiam also noted, “The other difference between various therapies that are out there is logistics, both in storage and administration. Some of these products have to be kept under certain temperature conditions, or they're given at a certain dosing regimen. Those details are going to become important to different patients as well.”

"At the end of the day, it's going to be unlikely that we're going to use a single therapy for all of our patients," says Vignesh T. Packiam, MD.

Recently recognized as a Surgical Review Corporation (SRC) Center of Excellence in Urology — a distinction earned by only 20 facilities nationwide —

 is setting a new standard for urologic care in the Erie region.

The recent expansion of AHN Saint Vincent Allied Urology was purposefully designed to enhance every aspect of the patient experience — from faster appointment scheduling to more comprehensive, on-site diagnostics. New offerings include 23 exam rooms, the region’s only Urodynamic testing suite, four dual procedure rooms, expanded telehealth and radiology services, and Erie’s only 3T MRI.

Among the advanced treatments available at AHN Saint Vincent is the

ProACT™ Adjustable Continence Device Therapy

— a new, minimally invasive, adjustable solution for men with mild to severe urinary stress incontinence, particularly those who are not ideal candidates for male slings or prefer to avoid an artificial urinary sphincter.

Michael Evankovich, MD, urologist at AHN Saint Vincent Allied Urology, is the only physician in the Erie region trained to perform the ProACT procedure.

ProACT involves the percutaneous placement of two small, adjustable balloons on either side of the urethra. Guided by fluoroscopy and cystoscopy, Dr. Evankovich navigates through two small perineal incisions to position the balloons without compromising the urethra, making the procedure well-suited for non-radiated patients with a history of prostatectomy or prior urethral surgery.

The balloons are adjusted gradually over time during quick, outpatient follow-up office visits to optimize continence based on the patient’s progress and level of improvement in dryness. The adjustments are generally simple and involve accessing small ports tunneled into the scrotum.

Urologists at AHN Saint Vincent collaborate across disciplines to manage urinary incontinence and related conditions. Initial treatment planning often includes assessing the effectiveness of lifestyle modifications or medication therapies either as standalone options or in combination with surgery.

If surgical intervention is required, AHN Saint Vincent’s expertise encompasses a broad spectrum of procedures — from minimally invasive endoscopic surgeries to more complex interventions, including:

With expanded capabilities and a patient-centered design, AHN Saint Vincent is providing comprehensive urologic care — from diagnostics through treatment and follow-up care — right here in Erie. To make a referral, call 

AHN Saint Vincent Allied Urology has been recognized as a Surgical Review Corporation Center of Excellence in Urology, one of only 20 nationwide. The facility has expanded to improve patient experience with faster scheduling, comprehensive diagnostics, and advanced treatments. Notably, it offers the ProACT™ Adjustable Continence Device Therapy, a minimally invasive solution for urinary stress incontinence. The center emphasizes collaborative care, integrating lifestyle modifications, medication, and surgical interventions. With its expanded capabilities, AHN Saint Vincent provides comprehensive urologic care from diagnostics to follow-up in Erie.

The recent expansion of AHN Saint Vincent Allied Urology was purposefully designed to enhance every aspect of the patient experience. 

Kristen R. Scarpato, MD, MPH

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