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

TAR-200 elicits high complete response rate in BCG-unresponsive NMIBC

The committee determined that the study was unlikely to meet its dual primary end points of radiographic progression-free survival and overall survival. 

Phase 3 trial of capivasertib in mCRPC discontinued following IDMC recommendation

Corinna Hughes, DNP, sits down with Amy Pearlman, MD, to discuss the evolving recognition of APPs in urology. 

Pearls & Perspectives: Evolving role of APPs in urology, with Corinna Hughes, DNP, at AUA 2025

Twelve-month physical functioning scores were comparable between the radical cystectomy arm and the bladder-sparing therapy arm.

CISTO: Radical cystectomy has key role in recurrent high-grade NMIBC

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"I think [gepotidacin] gives a different side effect profile available to the clinicians, and I think for patients as well, it provides a better, more durable option over time," says Ryan Haumschild, PharmD, MS, MBA, CPEL.

Expert discusses unique mechanism of action of UTI treatment gepotidacin

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. 

News

FDA accepts BLA for subcutaneous nivolumab in solid tumors

A 35-year-old male from Sudan was hospitalized with a right obstructing 1-cm ureteral stone seen on KUB. The KUB also revealed curvilinear calcification in the bladder wall. The patient was taken to the operating room for ureteroscopy and laser lithotripsy.

During cystoscopy, a rim of calcification was seen along the right ureteric ridge (figure 1a). A biopsy of this area was taken with the pathology shown in figure 1b.

B. Squamous cell carcinoma of the bladder

A 35-year-old male from Sudan presented with a 1-cm obstructing ureteral stone and curvilinear calcification in the bladder wall, as seen on KUB imaging. The patient underwent ureteroscopy and laser lithotripsy. During cystoscopy, calcification was observed along the right ureteric ridge. A biopsy was performed on this area to further investigate the pathology. The findings from the biopsy are crucial for understanding the underlying condition contributing to the calcification and obstruction, which may have implications for the patient's treatment and management.

A 35-year-old male from Sudan was hospitalized with a right obstructing 1-cm ureteral stone seen on KUB. The KUB also revealed curvilinear calcification in the bladder wall. The patient was taken to the operating room for ureteroscopy and laser lithotripsy. During cystoscopy, a rim of calcification was seen along the right ureteric ridge. What is the diagnosis?

Residents Corner

Quiz: Sandy patch on cystoscopy

Pearls & Perspectives: Future of reconstructive urology, with Ryan Terlecki, MD, at AUA 2025

, Amy Pearlman, MD, reconnects with her former fellowship director, Ryan Terlecki, MD, vice chair of Urology at Wake Forest and a leader in genitourinary reconstruction. Recorded at the 

American Urological Association's (AUA) 2025 Annual Meeting

 in Las Vegas, NV, their conversation explores the evolving definition of reconstruction, emerging surgical education formats, and the practical realities shaping the field.

Terlecki reflects on the growing emphasis on surgical video presentations at specialty meetings such as GURS, noting a generational shift in how urologists consume educational content—from textbooks to digital, video-based instruction. He outlines the logistical and technical challenges of producing high-quality surgical video, emphasizing the need for training programs to build AV infrastructure and digital literacy into their education models. As surgical teaching evolves, so too does the delivery of care, and Terlecki underscores the increasing importance of clinic-based procedures and patient-centered strategies in reconstructive urology.

The discussion also touches on burnout, surgical case complexity, and workforce trends. Terlecki notes a shift away from high-intensity surgeries among some early-career urologists, a reality that programs must acknowledge to maintain sustainability and meet patient demand. The role of international collaboration is also highlighted, with Terlecki discussing his nonprofit work delivering practical reconstructive training in resource-limited settings and how technology—particularly surgical video and translation tools—can help scale impact.

Looking ahead, he advocates for broader inclusion of outpatient and office-based procedures in reconstructive forums and cautions against drawing rigid lines between academic and community practice. Importantly, he calls for embracing wellness and lifestyle interventions—such as weight management—as core elements of reconstructive care, particularly for conditions like buried penis. His message: reconstruction must evolve beyond the operating room to include holistic, accessible, and efficient models of care.

A discussion on evolution of surgical education, importance of video training, and the future of patient-centered care in reconstruction.

Pearls & Perspectives, with Amy Pearlman, MD

Urologists from Cleveland Clinic have collaborated across borders to perform the world’s first remotely conducted robot–assisted high-intensity focused ultrasound (HIFU) focal therapy procedure for prostate cancer.

Remote operation for the HIFU procedure was conducted by Ruben Olivares, MD, of Cleveland Clinic’s main campus, who was more than 7000 miles away from the procedure that was performed at Cleveland Clinic Abu Dhabi.

Olivares was able to connect remotely to the Focal One System to lead treatment planning from Cleveland Clinic’s main campus in Ohio, in the United States. On-site procedural execution—including positioning the patient, preparing the HIFU system, and starting the procedure—was led by Waleed A. Hassen, MD, MBA, at Cleveland Clinic Abu Dhabi, in the United Arab Emirates.

“We are thrilled to have successfully performed the first-ever transcontinental robotic–assisted focal therapy procedure for prostate cancer by working in tandem with our partners at Cleveland Clinic Abu Dhabi,” said Olivares, a urologist in the Glickman Urological Institute at Cleveland Clinic, in a news release on the procedure.

 “Here at Cleveland Clinic, we use cutting-edge technology, but unfortunately, it's not available in many places throughout the US and in the world. We look forward to expanding the adoption of the latest alternative minimally invasive options and increasing access for patients throughout the world with this first step."

Overall, the HIFU procedure lasted approximately 1 hour, and no complications were reported. Olivares and Hassen collaborated in real-time during the procedure using shared Focal One system displays and an audio connection.

“There are many ways to treat prostate cancer, and one of the options is HIFU focal therapy. This is proof of principle that we can contour the prostate and design the plan remotely. This milestone is a testament to the power of collaboration and innovation,” said Hassen, who is the department chair of urology at the Surgical Subspecialties Institute at Cleveland Clinic Abu Dhabi. “By leveraging the expertise of our global network, we are not only providing patients with world-class care but also shaping the future of medical education and surgical innovation.”

The remote procedure was the product of nearly 2 years of planning. According to the news release from Cleveland Clinic, this planning included “testing various connectivity networks, working with cybersecurity teams, and navigating legal and ethical frameworks to ensure a secure and reliable process, with patient safety and quality being the primary goals.”

This marks the first time in the world that a procedure like this has been conducted, opening the door for expanded access to urologic care.

“We are witnessing the dawn of teletreatment,” said Jihad Kaouk, MD, FACS, enterprise chair of urology at Cleveland Clinic.

 “This innovative approach not only allows us to share expertise across Cleveland Clinic’s locations but also expands access to specialized care for patients, no matter where they are. Teletreatment offers a unique opportunity to improve health care delivery, enhance clinical training, and reduce global health disparities, bringing quality care to patients worldwide.”


1. Cleveland Clinic Abu Dhabi performs world’s first robotic-assisted, transcontinental ultrasound focal therapy procedure for prostate cancer. News release. Cleveland Clinic Abu Dhabi. April 16, 2025. Accessed April 17, 2025. https://www.mediaoffice.abudhabi/en/health/cleveland-clinic-abu-dhabi-performs-worlds-first-robotic-assisted-transcontinental-ultrasound-focal-therapy-procedure-for-prostate-cancer/

2. Cleveland Clinic performs first transcontinental robotic-assisted HIFU focal therapy procedure for prostate cancer. News release. Cleveland Clinic. April 18, 2025. Accessed April 18, 2025. https://consultqd.clevelandclinic.org/cleveland-clinic-leads-first-transcontinental-hifu-procedure-to-treat-prostate-cancer

Cleveland Clinic urologists have achieved a groundbreaking milestone by performing the first-ever remotely conducted robot-assisted high-intensity focused ultrasound (HIFU) focal therapy for prostate cancer. The procedure was executed transcontinentally, with Dr. Ruben Olivares operating from Ohio, USA, and Dr. Waleed A. Hassen managing on-site execution in Abu Dhabi, UAE. This innovative approach, a result of two years of meticulous planning, demonstrates the potential of teletreatment to enhance global healthcare access, improve medical education, and reduce health disparities by leveraging advanced technology and international collaboration.

“We are witnessing the dawn of teletreatment,” says Jihad Kaouk, MD, FACS. 

Urologists perform first remote robot–assisted HIFU for prostate cancer

Men receiving collagenase clostridium histolyticum (CCH, Xiaflex) for Peyronie’s disease appeared to have incremental benefits from each of 4 treatment cycles.

The finding was presented at the 2021 Sexual Medicine Society of North American Fall Scientific Meeting by Matthew J. Ziegelmann, MD, of Mayo Clinic, Rochester, Minnesota.

As explained by the investigators, the safety and efficacy of CCH had previously been demonstrated in two phase 3, randomized, double-blind, placebo-controlled trials in which CCH injections were administered in up to 4 treatment cycles at 6 week intervals. Each cycle comprised 2 injections administered 1 to 3 days apart. For the current study, the authors sought to evaluate incremental changes in penile curvature during the course of CCH treatment.

The investigators utilized pooled data from the 2 placebo-controlled trials to conduct a posthoc analysis. They calculated the change from baseline and from previous penile curvature measurement after each treatment cycle (weeks 6, 12, 18, and 24). A 2-sample t-test was used to compare mean percentage change in penile curvature. The percentage of patients who were classified as treatment responders (curvature reduction of at least 20%) was compared using Fisher’s exact test.

For the study, 832 men were evaluated, 551 of whom received CCH treatment and 281 of whom received placebo. At baseline, the mean ± standard deviation (SD) penile curvature was 50.6±14.7° in the CCH group and 50.4±14.1° in the placebo group. Compared with baseline, the mean ± SD percentage change in penile curvature was as follows:

• -12.8±20.3% for CCH vs -6.2±18.8% for placebo after the first treatment cycle

• -22.6±23.5% vs -10.6±23.1% after the second treatment cycle

• -29.9±25.0% vs -14.6±24.0% after the third treatment cycle

• -33.1±28.0% vs -16.6±25.5% after the fourth treatment cycle.

When comparing change from the previous measurement, ie, between first and second treatment cycle, between second and third treatment cycle, etc, mean ± SD percentage change in penile curvature was as follows:

• 11.1±21.8% vs 5.0±16.4% after the second treatment cycle (

• 9.6±21.8% vs 3.9±17.0% after the third treatment cycle (

• 6.3±23.0% vs 2.0±17.2% after the fourth (

In addition, the percentage of patients with at least a 20% reduction in penile curvature since the previous measurement was as follows:

• 29.9% for patients receiving CCH vs 18.3% in the placebo group after the first treatment cycle (

• 29.1% vs 16.9%, respectively, after the second treatment cycle (

• 25.2% vs 12.8%, respectively, after the third treatment cycle (

• 20.2% vs 10.9%, respectively, after the fourth treatment cycle (

The investigators also reported that in patients with a response after 2 treatment cycles, 40.2% of patients treated with CCH had an additional reduction in curvature of at least 20% after completing 4 treatment cycles vs 19.5% of patients receiving placebo (

= .001). In addition, in patients with less than a 20% reduction after 2 treatment cycles, 29.8% of patients receiving CCH were classified as treatment responders after completing the fourth treatment cycle compared with 20.8% of patients receiving placebo (

“Results would suggest benefits with performing a full series of 4 CCH injections, even among men who are initial non-responders,” the authors concluded.

1. Ziegelmann M, Liu G, McLane M, Hu Y, Trost L. Collagenase clostridium histolyticum treatment for Peyronie’s disease: analysis of outcomes and cumulative benefits after each injection cycle. Paper presented at 2021 Sexual Medicine Society of North American Fall Scientific Meeting; October 21-24; Scottsdale, Arizona. Abstract 059.

Collagenase clostridium histolyticum (CCH) treatment for Peyronie’s disease shows incremental benefits across four treatment cycles. A study presented by Dr. Matthew J. Ziegelmann at the 2021 Sexual Medicine Society of North America meeting analyzed pooled data from two phase 3 trials. The analysis revealed significant reductions in penile curvature with each CCH cycle compared to placebo. The percentage of patients achieving at least a 20% curvature reduction increased with each cycle. The findings suggest that completing all four CCH treatment cycles is beneficial, even for initial non-responders.

Ryan Haumschild, PharmD, MS, MBA, CPEL

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