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

Take a look through the novel agents that are set to further redefine the treatment landscape for high-risk BCG-unresponsive NMIBC.

Ongoing clinical trials and emerging agents in BCG-unresponsive NMIBC

Darolutamide plus ADT has also been approved in the US as well as in the European Union.

Health Canada approves darolutamide for metastatic castration-sensitive prostate cancer

“We hope our findings reassure health professionals caring for postmenopausal women with a history of stroke,” says Kimia Ghias Haddadan, MD. 

Vaginal estrogen tablets not linked with increased risk of recurrent ischemic stroke 

The presentations featured data on the drug candidate BOTRESO for BPH and LUTS, as well as on the prostate cancer prevention drug MCS-8.

Positive data on BOTRESO and MCS-8 highlight dual advances in prostate health 

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

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Santiago-Lastra is a urogynecologist and an associate professor of urology at the University of California, San Diego.

"The black box warning affects that ability for them to get access to that critical drug, vaginal estrogen," says Yahir A. Santiago-Lastra, MD.

Yahir A. Santiago-Lastra, MD, discusses barriers to vaginal estrogen access

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

Among patients with androgen receptor pathway inhibitor (ARPI)-refractory metastatic castration-resistant prostate cancer (mCRPC), continuation of an ARPI with [177Lu]Lu-PSMA-617 (lutetium Lu 177 vipivotide tetraxetan;Pluvicto) did not improve response rates nor overall survival (OS) compared with [177Lu]Lu-PSMA-617 alone, according to data published in 

The real-world analysis draws on results from the VISION trial, which demonstrated the safety of combining [177Lu]Lu-PSMA-617 with ARPIs.

“Our real-world analysis suggests that continuing the ARPI alongside [177Lu]Lu-PSMA-617 may not provide additional oncologic benefits for a VISION-like patient population, who have already progressed on an ARPI and other lines of systemic therapy,” said Miguel Muniz, MD, and Daniel S. Childs, MD, lead and senior authors of the paper, respectively, in correspondence with 

®. “We observed no improvement in the [prostate-specific antigen] PSA response rate nor overall survival after accounting for imbalances in baseline cohort characteristics.”

For the study, the investigators collected data on 256 patients with mCRPC from the Mayo Clinic Rochester radiopharmaceutical database. Among all patients identified, 106 (41.4%) received an ARPI alongside [177Lu]Lu-PSMA-617. According to the authors, “Those receiving an ARPI had lower baseline PSA levels (3.4 vs 29.7 ng/ml; 

 < .001) and lower rates of bone (77.4% vs 87.4%; 

Key outcomes of interest included the percentage of patients achieving a PSA response of 50% or greater (PSA50), the number of treatment cycles, and OS.

Overall, data showed that patients who received an ARPI were more likely to complete all scheduled treatment cycles, with 63.2% of patients in the ARPI arm completing all 6 cycles of [177Lu]Lu-PSMA-617 vs 48.7% of patients in the [177Lu]Lu-PSMA-617 monotherapy arm (

However, the addition of the ARPI did not appear to improve oncologic efficacy, with a similar PSA50 response rate across both arms. In total, 49.1% of patients in the ARPI arm achieved a PSA50 response vs 47.3% in the monotherapy arm (

On univariate assessment, OS was extended with continuation of an ARPI, with the median OS not reached in the ARPI arm vs 15.3 months in the [177Lu]Lu-PSMA-617 monotherapy arm (P < .001). However, this difference was not found to be significant on multivariate analysis after adjusting for baseline differences in other prognostic variables (HR, 1.03; 95% CI, 0.68 to 1.55; 

Based on these data, the authors suggest that continuation of an ARPI alongside [177Lu]Lu-PSMA-617 does not appear to provide any added oncologic benefit in APRI-refractory patients. However, they note several limitations of the current analysis, including its single-center, retrospective design as well as the lack of standardized radiographic response assessment. They expressed the need for a larger trial to confirm these findings.

To that point, Muniz and Childs added, “An ongoing, open-label phase II clinical trial (NCT05849298) is investigating whether combining [177Lu]Lu-PSMA-617 with an ARPI improves outcomes in a less heavily pre-treated patient population.”

The prospective randomized trial, called PSMACare, is expected to enroll 120 patients with PSMA-positive mCRPC across 50 global clinical trial sites.

 Primary completion of the study is expected in April 2028.

1. Muniz M, Sartor O, Orme JJ, et al. Outcomes for [177Lu]Lu-PSMA-617 with and Without concurrent use of androgen receptor pathway inhibitors in patients with metastatic castration-resistant prostate cancer. 

. 2025:S2588-9311(25)00175-0. doi:10.1016/j.euo.2025.06.004

2. A phase II study of AAA617 alone and AAA617 in combination with ARPI in patients with PSMA PET scan positive CRPC (PSMACare). ClinicalTrials.gov. Last updated August 14, 2025. Accessed August 20, 2025. https://clinicaltrials.gov/study/NCT05849298

A real-world analysis of patients with ARPI-refractory mCRPC indicates that continuing ARPI with [177Lu]Lu-PSMA-617 does not enhance response rates or overall survival compared to [177Lu]Lu-PSMA-617 alone. The study, based on data from the Mayo Clinic, showed no significant improvement in PSA response or survival after adjusting for baseline differences. Despite a higher completion rate of treatment cycles in the ARPI group, the oncologic efficacy remained similar. Limitations include the study's retrospective design and lack of standardized radiographic assessments, necessitating further trials.

Concurrent use of an ARPI with [177Lu]Lu-PSMA-617 did not improve response rates nor overall survival in patients with ARPI-refractory mCRPC.

Continuing an ARPI with [177Lu]Lu-PSMA-617 may not provide additional benefit in mCRPC 

The 40th Annual European Association of Urology Congress in Madrid, Spain, featured an extensive scientific program. In a recent video for 

, Betty Wang, MD, provided insight on 3 presentations that she believes “may be game changing” in urology.

The first study Wang highlighted was “Micro-ultrasound-guided versus MRI-guided biopsy for prostate cancer diagnosis: The OPTIMUM randomized clinical trial.”

“OPTIMUM was an international randomized study that compared micro-ultrasound guided vs MRI-guided biopsy for prostate cancer diagnosis,” explained Wang, a Society of Urologic Oncology fellow at Cleveland Clinic in Cleveland, Ohio.

“The authors noted that OPTIMUM demonstrated [that] micro ultrasound is non inferior to MRI fusion biopsy for detecting clinically significant prostate cancer and established itself as an appealing alternative to MRI for image guided biopsy. This would mean having a single procedure for both imaging and biopsy, and that could potentially be less expensive without using IV contrast, which is currently needed for multi-parametric MRIs,” Wang said.

The second study she highlighted was “Surgical outcomes and neoadjuvant safety with perioperative durvalumab for muscle-invasive bladder cancer (NIAGARA).”

 Previously reported data from the NIAGARA trial showed that perioperative durvalumab (Imfinzi) plus neoadjuvant chemotherapy extended event-free survival and overall survival vs neoadjuvant chemotherapy alone in muscle-invasive bladder cancer (MIBC).

 The FDA recently approved this treatment regimen for adult patients with MIBC.

At EAU, Wang said, investigators presented data on “the perioperative safety of durvalumab.”

“One of the main takeaways from this presentation was that durvalumab had no significant impact on the patient's ability to undergo surgery. In fact, if you look at the divide between the 2 arms, the addition of durvalumab actually increased the percentage of patients who underwent radical cystectomy from 83% (the chemo arm), compared to 88% (the chemo plus durvalumab arm). So if anything, it did not reduce the number of patients that could get their surgery in terms of cystectomy timing,” Wang said.

Betty Wang, MD, provided insight on 3 presentations that she believes “may be game changing” in urology.

Betty Wang, MD, recaps 3 key urologic cancer studies from EAU 2025

The final study Wang discussed was “AURORAX-0087A: Urine Glycosaminoglycan Scores for Surveillance of Recurrence in Intermediate and High-risk Non-metastatic Clear Cell Renal Cell Carcinoma - An Observational Prospective Multicenter Diagnostic Test Cohort Study.”

“This study demonstrates that urine GAGome scores can be a promising biomarker for clear cell RCC [renal cell carcinoma] recurrence. It has a 97% negative predictive value, meaning a negative test can almost definitely rule out a recurrence. In terms of clinical impact, this could potentially reduce unnecessary imaging costs and radiation exposure to the patient,” Wang said.

1. Kinnaird A, Luger F, Cash H, et al. Micro-ultrasound-guided versus MRI-guided biopsy for prostate cancer diagnosis: The OPTIMUM randomized clinical trial. Presented at: 40th Annual European Association of Urology Congress. March 21-24, 2025. Madrid, Spain

2. Catto JWF, Al-Ahmadie H, van der Heijden MS, et al. Surgical outcomes and neoadjuvant safety with perioperative durvalumab for muscle-invasive bladder cancer (NIAGARA) Presented at: 40th Annual European Association of Urology Congress. March 21-24, 2025. Madrid, Spain

3. Powles T, Catto JWF, Galsky MD. Perioperative durvalumab with neoadjuvant chemotherapy in operable bladder cancer. 

. 2024;391:1773-1786. doi:10.1056/NEJMoa2408154

4. FDA approves durvalumab for muscle invasive bladder cancer. News release. US Food & Drug Administration. Published online and accessed March 28, 2025. 

https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-muscle-invasive-bladder-cancer

5. Dabestani S. AURORAX-0087A: Urine Glycosaminoglycan Scores for Surveillance of Recurrence in Intermediate and High-risk Non-metastatic Clear Cell Renal Cell Carcinoma - An Observational Prospective Multicenter Diagnostic Test Cohort Study. Presented at: 40th Annual European Association of Urology Congress. March 21-24, 2025. Madrid, Spain

Betty Wang, MD, provides insight on 3 presentations that she believes “may be game changing” in urology.

Introducing First Assist: GU Oncology Unpacked!

First Assist: GU Oncology Unpacked, hosted by Taylor Goodstein, MD, is the latest multimedia program from Urology Times.

Introducing First Assist: GU Oncology Unpacked, with Taylor Goodstein, MD!

, host Taylor Goodstein, MD, sets the stage for a podcast designed to demystify the complex and fast-moving world of genitourinary oncology. Currently entering her second year of a Society of Urologic Oncology fellowship at Emory University after completing residency at The Ohio State University, Goodstein brings a unique “in-between” perspective—no longer a resident, not yet a long-established attending—offering listeners a relatable guide through one of urology’s most knowledge-dense subspecialties.

Speaking directly to trainees while ensuring relevance for seasoned clinicians, Goodstein acknowledges the steep learning curve in GU oncology and her mission to make it more approachable. She promises to ask the questions that others may hesitate to voice—like “What is CIS, anyway?” or “What does this chemotherapy cycle actually entail?”—and to explore these topics through interviews with leading urologists, radiation oncologists, medical oncologists, and basic scientists from across the country.

The podcast will span a wide range of subjects, from breaking trial data in non–muscle invasive bladder cancer to advances in focal therapy for prostate cancer to practical guidance for approaching an IVC thrombectomy. Episodes will blend guideline updates, expert commentary, and practical insights into both the “why” and the “how” of modern oncologic care.

The first series of episodes will take a historical look at how treatments for common urologic malignancies have evolved—because, as Goodstein notes, understanding where the field has been is essential to knowing where it’s going. Future episodes will intersperse this with timely, topic-driven conversations shaped in part by listener suggestions. (Please email us at UTeditors@mjhlifesciences.com with any suggestions.)

With a focus on accessibility, curiosity, and high-yield learning, 

 invites trainees and experts alike to engage in candid, informed discussions about the realities and innovations shaping GU oncology today.

 on Apple and Spotify, and stay tuned for insights on the past, present, and future of genitourinary oncology!

First Assist: GU Oncology Unpacked, hosted by Taylor Goodstein, MD, is the latest multimedia program from Urology Times.



Yahir A. Santiago-Lastra, MD

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