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

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For the trial, a biomarker will be utilized to aid in patient selection for the treatment.

FDA and EMA authorize phase 3 trial of masitinib for mCRPC

The application is supported by data from the phase 3 AMPLITUDE trial.

Expanded indication sought for niraparib plus AAP in Europe

Take a look through all the regulatory milestones in urology from the first half of the 2025.

Regulatory recap: FDA approvals in urology from the first half of 2025

Catch up on exclusive videos you may have missed from the first half of the year.

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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

The FDA has granted 510(k) clearance to a label expansion for the Rezūm System, raising the maximum prostate volume that can be treated with the device from 80 cm

 for patients with benign prostatic hyperplasia (BPH).

The device was previously approved in March 2019

 for patients with BPH with prostate volumes ranging from 30 cm

“The recent FDA-cleared indication expansion has increased the maximum prostate volume that can be treated with Rezūm Water Vapor Therapy from 80 grams to 150 grams," said Ron Morton, MD, chief medical officer, Urology, Boston Scientific. "Existing real-world and clinical trial data for Rezūm Therapy demonstrated safe and effective treatment of BPH in men with prostate volumes over 80 grams, with significant improvements in functional and quality of life outcomes. The indication expansion underscores Boston Scientific’s commitment to providing comprehensive options to treat men with symptomatic BPH."

Morton added, "The indication expansion for Rezūm Therapy is clinically important in the US as it provides physicians and patients another treatment option that doesn’t require general anesthesia when treating large prostate glands (defined as 80-150 grams by the American Urological Association). Rezūm Therapy continues to offer its intended benefits: it is minimally invasive, suitable for ambulatory settings and has no negative impact to sexual function."

The approval is supported by several studies highlighting the efficacy of Rezūm Water Vapor Therapy in patients with larger prostates. The first, published in 

 was a systemic review and meta-analysis suggesting that treatment with Rezūm provided a statistically significant and clinically meaningful improvement in short-term relief of lower urinary tract symptoms (LUTS) while demonstrating a low rate of adverse events (AEs) in men with prostate volumes of at least 80 cm

In total, the analysis included 15 studies (11 of which were retrospective studies) that included 471 patients with prostate volumes of at least 80 cm

. The median follow-up was 6 months (range, 3 to 17).

Overall, treatment with Rezūm led to statistically significant improvements in International Prostate Symptom Score (IPSS; mean change, -11.0; 95% CI, -12.2 to -9.7; 

 < .001), IPSS-QOL (mean change, -2.9; 95% CI, -3.5 to -2.4; 

 < .001), Qmax (mean change, 6.5 mL/s; 95% CI, 4.8 to 8.2 mL/s; 

 < .001), and post-void residual (mean change, -101 mL; 95% CI, -145 to -57; 

 < .001). There was no significant change in International Index of Erectile Function-Erectile Function (IIEF-EF; mean change: 0.3; 95% CI: -1.1, 1.6; 

Serious AEs were reported in less than 0.1% of patients (95% CI, 0.0% to 0.4%). Further, 1.2% of patients (95% CI, 0.0% to 3.5%) required surgical retreatment.

The FDA also reviewed data from a manufacturer-sponsored prospective, nonrandomized, single-arm study

 and compared these data to results from the pivotal trial of the Rezūm System.

“The clinical evidence showed overall comparable results between patients with prostate volumes [greater than] 80cm

 “Use of the proposed device in the expanded patient population does not result in any new concerns of safety or effectiveness.”

In total, the manufacturer-sponsored study included 47 patients with prostate volumes ranging from 80.8 cm

. Overall, 83% of patients demonstrated a response to treatment at 6-month follow-up. The average improvement in IPSS was 11.9 [plus or minus] 7.5 points at 6 months.

The study also met its primary safety end point, with no instances of device-related composite safety events.

According to the authors, these findings were consistent with those seen from the pivotal trial of Rezūm in prostate glands of up to 80 cm

. In total, the pivotal study included 197 patients who were randomly assigned to receive Rezūm (n = 136) or to the control arm (n = 61). Of the 61 patients in the control arm, 53 crossed over to receive Rezūm at the 3-month time point.

Five-year data from the pivotal trial showed that treatment with Rezūm reduced IPSS by 48% and BPH Impact Index by 48%. Further, patients who received Rezūm showed a 45% increase in quality of life and a 44% increase in maximum flow rate.

The retreatment rate at 5 years was 4.4%. No patients experienced device- or procedure-related sexual dysfunction or sustained de novo erectile dysfunction.

Results were similar among those in the crossover group.

1. Section 510(k) premarket notification for Rezum System. FDA. June 11, 2025. Accessed June 20, 2025. https://bostonscientific.showpad.com/share/fhLW6RP6GHlhhVecgQsXX

2. 510(k) premarket notification database. FDA. Accessed June 20, 2025. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250584

3. Section 510(k) premarket notification for Rezūm System. FDA. March 25, 2019. Accessed June 20, 2025. https://www.accessdata.fda.gov/cdrh_docs/pdf19/K190093.pdf

4. McVary KT, Miller LE, Bhattacharyya S, et al. Water vapor thermal therapy in men with prostate volume ≥80 cm3: a systematic review and meta-analysis. 

. 2024:184:244-250. doi:10.1016/j.urology.2023.10.036

5. Woo H, Levin R, Cantrill C, et al. Prospective trial of water vapor thermal therapy for treatment of lower urinary tract symptoms due to benign prostatic hyperplasia in subjects with a large prostate: 6- and 12-month outcomes. 

. 2023 Nov 8:58:64-72. doi:10.1016/j.euros.2023.10.006

6. McVary KT, Gittelman MC, Goldberg KA, et al. Final 5-year outcomes of the multicenter randomized sham-controlled trial of a water vapor thermal therapy for treatment of moderate to severe lower urinary tract symptoms secondary to benign prostatic hyperplasia. 

. 2021;206(3):715-724. doi:10.1097/JU.0000000000001778.

The FDA has expanded the label for the Rezūm System, allowing treatment of benign prostatic hyperplasia (BPH) in prostates up to 150 cm3, up from the previous 80 cm3 limit. This decision is based on studies demonstrating the system's efficacy and safety in larger prostates, with significant improvements in urinary symptoms and low adverse event rates. A manufacturer-sponsored study confirmed these findings, showing comparable results to the pivotal trial for smaller prostates. The Rezūm System continues to show promise in improving quality of life and urinary function without affecting sexual function.

The approval is supported by several studies highlighting the efficacy of Rezūm Water Vapor Therapy in patients with larger prostates.

FDA approves label expansion for Rezūm Water Vapor Therapy for BPH

One of many notable highlights from the 2025 American Urological Association Annual Meeting in Las Vegas, Nevada was the release of the “Genitourinary Syndrome of Menopause: AUA/SUFU [Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction]/[American Urogynecologic Society] Guideline.” In an interview with 

 described the significance of the new document.

“I think the best thing about these guidelines is their actual existence,” said Eilber, chair of the Cedars-Sinai Medical Group department of surgery and professor of urology, and associate professor of obstetrics & gynecology at Cedars-Sinai Medical Center in Los Angeles, California, and member of the plusOne Wellness Collective.

“Every woman who lives long enough will experience menopause, and over 85%—probably closer to 87%—of women will experience some symptom of genitourinary syndrome of menopause,” Eilber said.

Karyn S. Eilber, MD, reacts to the new genitourinary syndrome of menopause guidelines

Karyn S. Eilber, MD, shares her reaction to genitourinary syndrome of menopause guidelines

Eilber was also asked how clinicians can most effectively elicit and interpret subjective patient-reported symptoms to arrive at an accurate diagnosis, particularly in cases with overlapping urologic and gynecologic symptoms.

“I think 1 thing we need to do is get out of the habit of assuming that certain symptoms are due to common conditions. When a woman complains about urinary frequency, urgency, burning with urination, we will treat her for urinary tract infection over and over again, despite tests being negative. We see this with interstitial cystitis. We see this with GSM. Even in men, if they have frequency, we always assume it's BPH [benign prostatic hyperplasia], regardless of whether they're responding to BPH treatments or not. I think 1 thing they need to do is get out of the habit of just treating everything with these types of symptoms as a UTI,” Eilber said.

“I think the best thing about these guidelines is their actual existence,” says Karyn S. Eilber, MD.

Former President Joe Biden has been diagnosed with grade group 5 de novo metastatic hormone-sensitive prostate cancer, according to a recent announcement from his office.

 This diagnosis has raised important discussion surrounding 

, a urologist at Cedars-Sinai Medical Center in Los Angeles, who is not involved with President Biden’s care, walked through the current recommendations for prostate cancer screening.

According to Weiner, it is recommended that men begin screening around ages 50 to 55 years. Some men who are higher risk for prostate cancer—such as those of African ancestry, those with a family history of prostate cancer, and those with genetic alterations that place them at higher risk—may initiate screening earlier.

Weiner also noted, “As important as the age of starting to screen is the age to decide to stop screening. While some guidelines provide a strict age cutoff, typically 70, in terms of probably when the risk of screening outweigh the benefits, the true conversation comes between the primary care provider and the patient themselves.”

Adam B. Weiner, MD, walks through the current recommendations for prostate cancer screening in light of President Joe Biden's recent prostate cancer diagnosis

Prostate cancer screening: Expert weighs in after Biden's diagnosis

According to Adam B. Weiner, MD, a urologist at Cedars-Sinai Medical Center, men should begin prostate cancer screening around ages 50 to 55. 

Kevin C. Smith

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