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Pfizer has chosen to no longer pursue an expanded indication for talazoparib plus enzalutamide in non-HRR gene mutated mCRPC in the US as a result of this decision.

FDA does not approve talazoparib plus enzalutamide for non-HRR gene mutated mCRPC

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

The bkActiv S series is designed to guide nonsurgical urologic, colorectal, and pelvic floor procedures. 

Ultrasound imaging system now available to guide nonsurgical urology procedures

 is compliance officer and medical director of coding and reimbursement, United Urology Group and Chesapeake Urology, in Towson, Maryland.

"We believe the confusion comes from the typical lexicon surgeons use when performing surgeries, rather than the actual code descriptor and the procedure performed," write Jonathan Rubenstein, MD, and Mark Painter.

CPT 49186 vs 38780: Coding retroperitoneal mass excision

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

Urology Times is the leading resource for urologists & allied health professionals offering clinical analysis, policy perspectives, & practical advice.

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"Ultimately, there is no 'right choice' when it comes to urinary diversion," writes Anne K. Schuckman, MD.

What determines the optimal urinary diversion?

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

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. 

NOINDEX

NOFOLLOW

AHN Offering Advanced Urological Care Close to Home for Patients in Erie

 (Jun. 2, 2025) — The University of Miami Board of Trustees has unanimously selected 

 as the next Chief Executive Officer of UHealth, as well as Executive Vice President for Health Affairs at the University of Miami, effective immediately. Dr. Parekh, a globally renowned urologic oncologist, healthcare innovator, and leader in academic medicine has served as the Chief Operating Officer of the University of Miami Health System since 2020, and alongside University of Miami President Joseph J. Echevarria jointly engineered UHealth’s dramatic turnaround over the last five years.

“Dipen has played a pivotal role each step of the way as the University of Miami Health System has grown into one of the top academic medical centers in the country,” noted President Echevarria. “He understands the mission—from the operating room to the classroom to the boardroom—and he embodies the excellence we strive to deliver for our patients, students, and community.”

“As Joe ascended to become President of the University of Miami a year ago, Dipen’s talent, experience, academic pedigree, and work ethic made him the right choice to become CEO of the health system,” Stuart Miller, Chair of the UHealth Board of Directors explained to his fellow University of Miami Trustees at the Annual Meeting of its Board on May 30. “While Joe will continue to be the President of both the University and UHealth, Dipen will leverage his considerable skills and credibility as a surgeon, clinical leader, and NCI-funded scientist with over 200 peer reviewed publications, to lead the stellar faculty and clinicians at South Florida’s only academic health system, and to enhance our critical community partnership with Jackson Health System.”

While serving as Chief Operating Officer of UHealth, in 2021 Dr. Parekh was named Executive Dean for Clinical Affairs at the Miller School of Medicine, where he has worked to build synergy between the academic and clinical missions at the University of Miami. He is laser-focused on ensuring UHealth becomes a leader in developing and deploying emerging and effective treatments to improve wellbeing in Miami and beyond. His success has been nationally recognized, with Becker’s Hospital Review naming him among the top 60 academic health system COOs to know in 2024.

Having joined the institution in 2012 as Chair of the Department of Urology, Dr. Parekh’s first system-wide administrative role was as Chief Clinical Officer from 2017-2020. He is also an endowed professor of urology and the founding director of the Desai Sethi Urology Institute.

As a global leader in academic medicine, Dr. Parekh led a groundbreaking trial, published in 

 in 2018, which established the efficacy of robotic-assisted surgery for bladder cancer. He is a member of the Academy of Science, Engineering, and Medicine of Florida (ASEMFL), the American Association of Genitourinary Surgeons, and the Clinical Society of Genitourinary Surgeons.

Over the course of his career, Dr. Parekh has performed more than 6,000 robotic urologic cancer surgeries, making him one of the most experienced practitioners worldwide. As he has throughout his tenure at the University of Miami, Dr. Parekh will continue to treat patients.

“Dipen has excelled not only in managing day-to-day operations at UHealth, but in setting forward-looking strategy and embracing continuous improvement as our talented clinicians and faculty navigate an increasingly dynamic environment,” added University of Miami Board Chair Manny Kadre. “Dr. Parekh and President Echevarria are a proven, winning combination for our health system and community, who have the Board’s full support.”

“I am profoundly grateful for the trust placed in me and energized by the opportunity to advance our shared mission of delivering world-class care, pioneering research, and transformative education,” said Dr. Parekh in accepting the appointment. “I look forward to working with our exceptional faculty, staff, and our key partner, the Jackson Health System, to lead us into this next chapter, one grounded in collaboration, compassion, and a bold vision for the future of academic medicine.”

Dr. Dipen J. Parekh has been appointed as the CEO of UHealth and Executive Vice President for Health Affairs at the University of Miami. With a distinguished career in urologic oncology and academic medicine, Dr. Parekh has been instrumental in UHealth's transformation into a leading academic medical center. His leadership, alongside University President Joseph J. Echevarria, has been pivotal in this success. Dr. Parekh's extensive experience in clinical and academic roles, including groundbreaking research, positions him to further advance UHealth's mission of excellence in healthcare, research, and education.

Award-winning COO of UHealth, renowned surgeon scientist, and director of the Desai Sethi Urology Institute elevated to lead patient-focused care, biomedical research, and medical education

Anne K. Schuckman, MD

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