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

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This article provides a practical explanation of MACRA and the Quality Payment Program and what they mean for practicing urologists.

MACRA: A practical perspective for urologists

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

Use of botulinum toxin (IncoA, Xeomin) with an anti-nausea patch appears to mitigate salivary gland toxicity in patients with metastatic prostate cancer who are undergoing prostate-specific membrane antigen (PSMA)-directed radiopharmaceutical therapy.

Investigators reported at the Society of Nuclear Medicine and Molecular Imaging 2025 Annual Meeting that this approach was associated with a 30% decrease in PSMA uptake by the salivary glands without compromising the treatment’s efficacy.

“In order for patients to maintain a good quality of life and continue with their treatments, it’s essential to address these serious dry mouth issues. Our study explored the use of Botox paired with a nausea patch on reducing radiation uptake to the salivary glands,” said Tianzhi Zhao, research assistant at the Theranostics Centre of Excellence in the Yong Loo Lin School of Medicine at the National University of Singapore, in a news release about the results.

“While TANDEM therapy strategies with combined 

Lu-PSMA-targeted RLT in a single low-activity cycle address certain challenges, effective salivary gland protection remains critical,” the authors wrote in their abstract.

The study evaluated data from 14 patients, with a mean age of 68.0 ± 8.1 years. Patients received percutaneous injections of 250 units of IncoA prior to their scheduled PSMA radioligand treatments. These were injected in 1 parotid gland as well as the contralateral submandibular glands 3-4 weeks for before 

Ac-radioligand therapy. Patients also received transdermal scopolamine patches behind the ears starting 72 hours before radioligand therapy and remaining until 2 hours post radioligand therapy. PSMA uptake in the salivary glands was evaluated using SPECT/CT imaging.

The investigators reported that the cohort received 1 to 2 cycles of treatment with 

Ac (6.87 ± 3.14 MBq) per cycle, and received a total of 16 IncoA treatments. The cohort was heavily pretreated, with “a median PSA [prostate-specific antigen] level of 59 [ng/mL] (range, 17.2 [ng/mL] to 2130.0 [ng/mL]) and a mean Karnofsky performance score of 85.0 ± 11.6,” according to the abstract. Four patients in the cohort received only IncoA; the remaining patients received both IncoA and scopolamine patches.

When comparing the IncoA-treated parotid glands with the opposite parotid gland, investigators reported a mean 30% reduction in PSMA uptake in the IncoA-treated glands. With the submandibular glands, a mean 17% reduction in PSMA uptake was observed in the IncoA-treated glands vs the opposite glands. The regimen was found to be well tolerated, with no serious or systemic adverse events reported. In addition, there was no discontinuation of PSMA treatment due to dry mouth.

“This study demonstrates that Botox, administered at recommended doses in combination with a nausea patch, offers a promising therapeutic strategy for reducing radiation-induced salivary gland toxicity without compromising PSMA tumor uptake,” said Jingjing Zhang, MD, PhD, assistant professor at the Theranostics Centre of Excellence in the Yong Loo Lin School of Medicine at the National University of Singapore, in the news release. “The significance of this work lies in its direct patient benefit and its potential to expand the therapeutic utility of PSMA radiopharmaceutical therapy, particularly with alpha-emitting radionuclides like 

1. Zhao T, Mueller J, Fan X, Jakobsson V, Zhang J, Baum RP. Botulinum toxin plus scopalamine as a protective strategy against salivary gland toxicity in patients treated with 225Ac- and 177Lu- PSMA-targeted radioligand therapy (TANDEM PSMA-RLT). 

2. Botox mitigates debilitating dry mouth in prostate cancer patients receiving radiopharmaceutical therapy. Society of Nuclear Medicine and Molecular Imaging. June 24, 2025. Accessed June 25, 2025. https://www.eurekalert.org/news-releases/1088797

Botulinum toxin (IncoA, Xeomin) combined with an anti-nausea patch effectively reduces salivary gland toxicity in metastatic prostate cancer patients undergoing PSMA-directed radiopharmaceutical therapy. This approach results in a 30% decrease in PSMA uptake by the salivary glands without affecting treatment efficacy. The study involved 14 patients, with IncoA injections and scopolamine patches administered before radioligand therapy. The treatment was well tolerated, with no serious adverse events or treatment discontinuations due to dry mouth, highlighting its potential to enhance PSMA radiopharmaceutical therapy's therapeutic utility.

The approach was associated with a 30% decrease in PSMA uptake by the salivary glands without compromising the treatment’s efficacy.

Botulinum toxin reduces PSMA therapy-related salivary gland toxicity

Updated data from the phase 2/3 QUILT-3.032 trial (NCT03022825) presented at the 

2025 American Urological Association Annual Meeting

 in Las Vegas, Nevada, demonstrate high complete response (CR) and avoidance of cystectomy rates in patients with high-risk BCG-unresponsive bladder carcinoma in situ (CIS), with or without papillary disease, treated with nogapendekin alfa inbakicept-pmln (NAI; Anktiva).

“This IL-15 superagonist does several things uniquely. First of all, within the bloodstream, you have actually an increased duration or half life. You have an ability to improve binding and then accelerate its ability to bring about an improvement in the immune response. We have proliferation and activation of natural killer cells. We have an impact on the dendritic as well as the T cells themselves, and it’s a combination of increasing this cell kill but not yet stimulating the suppressive T regulatory cells that make this IL-15 superagonist unique,” said QUILT-3.032 principal investigator Sam S. Chang, MD, MBA, professor of urology and Chief Surgical Officer of the Vanderbilt Ingram Cancer Center in Nashville, Tennessee.

Chang also gave an overview of the QUILT-3.032 study, an open-label, single-arm multicenter trial evaluating NAI in patients with BCG-unresponsive NMIBC. The trial included cohort A, which included 100 patients with BCG-unresponsive NMIBC carcinoma in situ (CIS) with or without papillary disease, and cohort B, which included 80 patients with BCG-unresponsive NMIBC papillary disease without CIS. In the induction phase, patients in both cohorts received 400 ug NAI plus 50 mg BCG intravesically for 6 consecutive weeks. There was also a re-induction phase for participants who had not achieved a CR at month 3. The primary end point for cohort A was biopsy-confirmed CR rate that was based on responses at 3- or 6-month assessment. The primary end point for cohort B was disease-free rate assessed at the end of 12 months.

In cohort A, the CR rate 71% (95% CI: 61.1-79.6). The duration of CR in the 71 evaluable responders ranged up to more than 53 months. The cystectomy-free rate at 36 months was 84%. At 36 months, disease-specific overall survival was 99%.

“Exceptional ongoing complete response data were presented for the FDA label population (N=77), which has a longer follow-up time of 29.3 months and showed a 51% probability of duration of complete response of at least 45 months,” ImmunityBio noted in a news release.

In cohort B, disease-free survival at 12 months was 58% (95% CI: 46.6-68.2) and at 24 months was 52% (95% CI: 40.3-62.7). Median disease-free survival was 25.3 months (95% CI: 9.8-40.1). Chang also reported that in this cohort, treatment with NAI plus BCG yielded cystectomy avoidance rates of 92% at 12 months and 82% at 36 months. The latter figure, according to the presentation, “is the highest percentage of bladder sparing and longest duration available to date in BCG-unresponsive NMIBC papillary disease without CIS.”

Regarding safety, Chang said, “I think importantly, one needs to know that within this trial, there were no grade 4 or grade 5 AEs [adverse events] and overall for grade 3, the treatment-associated side effect [rate] was 3%.”

“Although BCG is the commonly used first-line therapy for newly diagnosed high-risk non-muscle invasive bladder cancer, many patients will be refractory or relapse after an initial response and be diagnosed as BCG-unresponsive. Our latest findings, including an 82% cystectomy avoidance rate, provide additional evidence that ANKTIVA has the ability to restore BCG activity and promote durable complete responses and, most importantly, help patients preserve their bladder for a prolonged duration from surgery in both CIS, as well as papillary without CIS disease,” Chang said in the news release.

Executive Chairman and Global Chief Medical and Scientific Officer of ImmunityBio Patrick Soon-Shiong, MD, also commented on the data in the news release, saying, “We are pleased with these unmatched long-term follow up results which further illustrate ANKTIVA’s potential to improve outcomes and quality of life for patients with non-muscle invasive bladder cancer in both indications of CIS, as well as papillary disease without CIS. The cystectomy avoidance rate of greater than 82% at 36 months in both BCG-unresponsive CIS with or without papillary disease and in BCG-unresponsive papillary without CIS disease is the highest percentage of bladder sparing and longest duration of complete response and disease-free status seen in this patient population to date, as confirmed by all the studies presented in the field at the AUA 2025 conference. We look forward to the national guidelines (NCCN) for BCG-unresponsive papillary disease without CIS to align with these long-term data of cystectomy avoidance and the data presented at AUA supporting Anktiva as the best in class and best in disease for this indication.”

ImmunityBio recently announced that it has submitted a supplemental biologics license to the FDA seeking an expanded approval for NAI in combination with BCG for BCG-unresponsive NMIBC in the papillary indication.

1. Chang SS, Chamie K, Kramolowsky E, et al. An update on QUILT-3.032: Complete responses to N-803 plus BCG therapy in BCG-unresponsive bladder carcinoma in situ (CIS) with or without Ta/T1 papillary disease. 

. 2025;213(5S):e392. doi:10.1097/01.JU.0001109848.08748.9e.12

2. Unmatched long-term bladder preservation for 36 months in over 80 percent of responders with ANKTIVA® plus BCG in BCG-unresponsive NMIBC CIS and papillary disease alone – best in disease and best in class with 5 year follow-up. News release. ImmunityBio. April 28, 2025. Accessed April 28, 2025. https://www.businesswire.com/news/home/20250428844244/en/Unmatched-Long-Term-Bladder-Preservation-for-36-Months-in-over-80-percent-of-Responders-with-ANKTIVA-Plus-BCG-in-BCG-Unresponsive-NMIBC-CIS-and-Papillary-Disease-Alone-Best-in-Disease-and-Best-in-Class-with-5-Year-Follow-Up

3. ImmunityBio announces FDA submissions of supplemental BLA for NMIBC papillary disease and for expanded access of ANKTIVA to treat lymphopenia. News release. ImmunityBio. April 15, 2025. Accessed April 15, 2025. https://immunitybio.com/immunitybio-announces-fda-submissions-of-supplemental-bla-for-nmibc-papillary-disease-and-for-expanded-access-of-anktiva-to-treat-lymphopenia/

Updated data from the QUILT-3.032 trial reveal promising outcomes for patients with high-risk BCG-unresponsive bladder carcinoma in situ treated with nogapendekin alfa inbakicept-pmln (NAI; Anktiva). The trial demonstrated high complete response rates and significant cystectomy avoidance, with a 71% CR rate in cohort A and a 58% disease-free survival at 12 months in cohort B. The treatment showed a favorable safety profile, with no grade 4 or 5 adverse events. These findings suggest NAI's potential to enhance BCG efficacy and improve patient outcomes.

In cohort A, the cystectomy-free rate at 36 months was 84%. 

Nogapendekin alfa inbakicept shows high CR, avoidance of cystectomy in NMIBC

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

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.

Franklin D. Gaylis, MD

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