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

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"The past month has been an active one for developments in Washington that impact health care, from proposed budget cuts to modernizing the Stark Law and boosting Graduate Medical Education funding," writes the AACU's Raymond Nicholas.

Spring brings budget cuts, Stark debate, and hope for GME

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

News

FDA accepts new drug application for zoliflodacin for uncomplicated gonorrhea

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

Bone Predominant mCRPC Patient Case

Video content above is prompted by the following:

What are your initial impressions of the case?

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

Pearls & Perspectives: Expanding BPH care & patient choice, with Kevin Zorn, MD, at AUA 25

, host Amy Pearlman, MD, is joined by Kevin Zorn, MD, at the American Urological Association meeting in Las Vegas. They dive into the evolving landscape of 

 treatment—covering everything from personalized care in private practice to research collaborations that stretch far beyond traditional academic walls.

Zorn shares his journey from academia to opening BPH Canada, a center focused on comprehensive, individualized care for men dealing with prostate issues. He explains how moving out of an academic setting has actually allowed him to do 

 research, not less—thanks to flexible structures, external IRBs, and strong collaborations through groups like ICARUS.

They talk about the rapid expansion of BPH technologies and how Zorn’s approach is to offer the full range—not just what’s convenient or available in one setting. “No man should feel steered into a treatment because it’s the only one on the shelf,” he says. From UroLift to Aquablation and beyond, he outlines how shared decision-making is only meaningful when patients truly have options.

Zorn also previews his plenary talk on ejaculatory preservation, calling it a critical piece of informed consent that’s too often brushed aside. They cover what techniques can help preserve function, how to talk to patients about it, and why it’s time to ditch the “less mess” joke.

They close by discussing a supplement aimed at ejaculatory volume, real patient conversations about sex and expectations, and why old questionnaires might not capture the full story. For Zorn, it all comes back to one thing: treating patients like people, not procedures.

Urologists discuss innovative BPH treatments, emphasizing personalized care, and the importance of ejaculatory preservation.

BPH Videos

Videos

Pearls & Perspectives, with Amy Pearlman, MD

My physician performed an open radical nephrectomy but also removed a 4-cm and a 3-cm peri-aortic metastatic mass. What code or codes should I report? I believe that a radical nephrectomy includes regional lymph node dissection, so I was thinking of reporting 50230.

A coder would need to understand the details of the operative note to confirm the appropriate coding.

50320’s description reads “Nephrectomy, including partial ureterectomy, any open approach including rib resection; radical, with regional lymphadenectomy and/or vena caval thrombectomy

”As one can see, the code includes a regional lymphadenectomy if performed. However, the question indicates that the 4- and 3-cm peri-aortic masses may have been noncontiguous masses that were removed in addition to the radical nephrectomy.

If questions remain after reading the operative note, the physician should be consulted and the note amended to clarify any questions. Once the operation is clear and supported by the documentation, coding would be based on the indicated procedure.

• If the final operative note supports that the radical nephrectomy was performed and that the 4-cm and 3-cm peri-aortic masses removed were separate (noncontiguous) from the renal tissue removed instead of lymph nodes removed with surrounding tissue, one would report 50320 and 49187 (Excision or destruction, open, intra-abdominal [ie, peritoneal, mesenteric, retroperitoneal], primary or secondary tumor(s) or cyst(s), sum of the maximum length of tumor(s) or cyst(s); 5.1-10 cm)

A couple of notes: 1) The regional lymph node resection, as it is listed as included instead of with the description as part of the primary procedure, is not required to be performed to meet the definition of a radical nephrectomy. We have seen numerous coders misinterpret the word “includes” when incorporated into a 

 description. The word “includes,” when used in this context for 

, means that if performed, the service is not allowed to be reported separately if performed during the same operation; however, it does not mean it is required to support the use of the code if the primary procedure is performed, and 2) the use of the 49186-49190 code series is allowed to be reported if the mass is not contiguous or separate from the primary tumor and the tumors removed are summed and reported with the appropriate code from the series instead of reported separately for each code.

• If the final operative note supports that the lymph nodes were removed with the surrounding tissue, it might be appropriate to report only code 50320 with or without modifier -22 based on the total work effort required for the procedure.

As always, we encourage you to communicate among all team members and pay attention to your documentation. Finally, the medical necessity of the service needs to be expressed within the documentation submitted.

Send coding and reimbursement questions to Jonathan Rubenstein, MD, and Mark Painter c/o

The information in this column is designed to be authoritative, and every effort has been made to ensure its accuracy at the time it was written. However, readers are encouraged to check with their individual carrier or private payers for updates and to confirm that this information conforms to their specific rules.

"The medical necessity of the service needs to be expressed within the documentation submitted," write Jonathan Rubenstein, MD, and Mark Painter.

Understanding 50320: Radical nephrectomy and lymph nodes

Computational Histology Artificial Intelligence (CHAI) biomarkers demonstrated the ability to prognosticate outcomes for patients with high-grade (HG) Ta non–muscle-invasive bladder cancer (NMIBC), according to data published in 

According to Valar Labs, which developed the Vesta platform that uses CHAI biomarkers, this patient population is “frequently on the borderline of guideline-based risk stratification [and] may receive different treatment depending on which guideline their provider uses.”

The CHAI platform was designed to assess risk of recurrence and progression in these patients by quantifying “histologic features, including tumor cell morphology and tumor microenvironment, from digital whole-slide images,” the authors explained.

“HG Ta tumors carry differing risks [that] current guidelines attempt to address, and clinical factors such as tumor focality and size can help delineate the true nature of these tumors. These clinical factors, however, are somewhat crude and can be misleading at times,” explained lead author Sam S. Chang, MD, MBA, Chief Surgical Officer of Vanderbilt Ingram Cancer Center, Nashville, Tennessee, in a news release from Valar.

 “This study demonstrated that CHAI biomarkers can offer improved and additional risk stratification that can go beyond traditional risk factors to better prognosticate outcomes in this population.”

For the study, the investigators assessed the ability of the CHAI platform to predict the risk of recurrence and progression in a retrospective multicenter cohort of 269 patients with high-grade Ta disease. They then compared the performance of the platform to existing American Urological Association (AUA) and European Association of Urology (EAU) models. CHAI biomarker status was classified as either being present (indicative of higher risk) or absent. The median follow-up was 32 months (IQR, 14 to 52).

Data showed that EAU risk group was not significantly associated with high-grade recurrence-free survival (RFS) on either univariate analysis (high risk vs intermediate risk; HR, 1.47; 95% CI, 0.96-2.23; 

 = .074) or multivariable analysis adjusted for CHAI biomarker status. AUA high-risk was significantly associated with high-grade RFS on univariate analysis (HR, 1.93; 95% CI, 1.07-3.48; 

 = .029), but the association did not remain significant when accounting for CHAI biomarker status.

The CHAI biomarker, however, demonstrated the ability to stratify outcomes independent of these risk groups. The presence of the CHAI biomarker was found to be significantly associated with high-grade RFS on both univariate analysis (HR, 2.23; 95% CI, 1.45-3.44; 

 < .001) as well as multivariate analysis when adjusting for AUA and EAU risk groups or their individual components.

The authors also noted, “The continuous output for the CHAI biomarker had higher [areas under the curve] than the AUA and EAU risk groups for prediction of both endpoints along all time points.”

There was also an association observed between the AI pathology component of the CHAI biomarker (with tumor multifocality excluded) and high-grade RFS. On multivariate analysis, the AI pathology component alone provided prognostic information beyond AUA risk (HR, 2.21; 95% CI, 1.42-3.43; likelihood ratio 

< .001) and EAU risk (HR, 2.19; 95% CI, 1.40-3.43; likelihood ratio 

Likewise, neither EAU (HR, 1.32; 95% CI, 0.40 to 4.32;

 = .7) nor AUA risk groups (HR, 1.39; 95% CI, 0.30-6.44; 

 = .7) were significantly associated with muscle-invasive bladder cancer (MIBC) progression-free survival (PFS). However, there was a significant association between the AI component of the CHAI biomarker and MIBC-PFS (HR, 4.55; 95% CI, 1.39-14.92; 

The association of CHAI biomarker with RFS and PFS was maintained even after the investigators excluded patients who had concurrent carcinoma in situ.

The authors noted that if the CHAI biomarker had been used to determine risk rather than the EAU and AUA stratifications, approximately 70% of patients deemed as having high risk would have been classified as being closer to intermediate risk. Further, 9.5% of patients designated as intermediate risk would have been classified as being at higher risk for recurrence and progression.

Senior author Siamak Daneshmand, MD, of the University of Southern California, concluded in the news release,

 "The ability to derive clinically meaningful predictive and prognostic information from routinely-collected pathology is a paradigm shift for the risk stratification of bladder cancer patients."

1. Chang SS, Launer B, Narayan V, et al. Computational histology artificial intelligence (CHAI) enhances risk stratification of high-grade Ta non–muscle-invasive bladder cancer in a multicenter cohort: comparison to current European Association of Urology and American Urological Association stratification schemes. 

. Published online June 12, 2025. doi:10.1016/j.eururo.2025.05.035

2. Valar Labs’ CHAI biomarkers validated in new study in European Urology for predicting outcomes of high grade Ta bladder cancer. News release. Valar Labs. June 13, 2025. Accessed June 13, 2025. https://www.businesswire.com/news/home/20250612200267/en/Valar-Labs-CHAI-Biomarkers-Validated-in-New-Study-in-European-Urology-for-Predicting-Outcomes-of-High-Grade-Ta-Bladder-Cancer

Computational Histology Artificial Intelligence (CHAI) biomarkers have shown promise in improving risk stratification for patients with high-grade Ta non–muscle invasive bladder cancer. The CHAI platform, developed by Valar Labs, quantifies histologic features from digital whole-slide images to assess recurrence and progression risks. In a study of 269 patients, CHAI biomarkers outperformed existing American Urological Association (AUA) and European Association of Urology (EAU) models in predicting outcomes. The study suggests that CHAI biomarkers could redefine risk categories, potentially altering treatment decisions for many patients.

The CHAI biomarker was shown to outperform EAU and AUA stratifications. 

Raymond Nicholas

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