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A recap of the FDA submissions and regulatory decisions in urology from February 2025. 

FDA updates in urology: February 2025

Overall, 84.2% of patients achieved a 50% or greater reduction in urgent leaks.

Pivotal study data show efficacy of percutaneous SNM device for UUI 

The updates emphasize a risk-stratified approach to the management of microhematuria.

AUA, SUFU release amendment to microhematuria guideline

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

"For telephone-only (audio only) visits, Medicare has officially stated that such a visit would be considered the same as an in-person visit, with a few qualifications," write Jonathan Rubenstein, MD, and Mark Painter.

How to bill for telephone-only urology visits

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“Black patients have over 2-fold excess mortality compared to White men, and that has been fairly consistent; the actual rate ratio has hovered between 2 and 2.5 for many years,” says Matthew R. Cooperberg, MD, MPH. 

Matthew Cooperberg, MD, on racial disparities in prostate, bladder cancer outcomes 

“It does seem clear that we need to get back to a smarter middle ground of screening—using screening more intelligently, finding the high-grade cancers and treating them—so that we can get that mortality curve back on a downward trajectory,” says Matthew R. Cooperberg, MD, MPH. 

Matthew Cooperberg, MD, reacts to 2025 ACS prostate cancer data

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

The target enrollment has been met in the pivotal VAPOR 2 trial (NCT05683691), assessing the safety and efficacy of the Vanquish water vapor ablation device in patients with intermediate-risk, localized prostate cancer, Francis Medical, Inc, announced in a news release.

In total, the trial enrolled 235 patients across 26 clinical trial sites in the US. All patients enrolled in the study have completed their initial treatment.

"We are thrilled to announce the completion of enrollment in the VAPOR 2 study ahead of our expected timeline," said co-principal investigator Samir Taneja, MD, of NYU Langone Health, in the news release.

 "For a study of this scale to finish enrollment early is a remarkable achievement and speaks to the dedication of our participating investigators and the level of excitement surrounding this promising technology."

Overall, the prospective, multicenter, single-arm VAPOR 2 study is assessing the safety and efficacy of Vanquish in adult patients with Gleason grade 2 prostate cancer.

 Those enrolled in the study will receive transurethral delivery of water vapor ablation.

To be eligible for enrollment, patients needed to be at least 50 years of age and have a life expectancy of at least 10 years. Participants must also have a prostate size between 20 cc and 80 cc, a prostate-specific antigen level of 15 ng/mL or lower, and a cancer stage less than or equal to T2c, among other requirements.

The primary effectiveness end point is freedom from systemic disease, systemic therapy, salvage therapy, and a Gleason grade group of 2 or higher at 36 months. The primary safety end point is the proportion of patients who are free from new or worsening urinary incontinence at 12 months. A key secondary end point of the trial is the proportion of patients who are free from impotence at 36 months.

Patients in the study will continue to be followed for up to 5 years to assess long-term outcomes. Primary completion of the trial is expected in April 2027.

According to Francis Medical, the Vanquish device is “designed to use phase shift energy stored in sterile water vapor to convectively transfer thermal energy to cancerous tissue, causing cell death.” The FDA granted a breakthrough therapy designation to the device in August 2023.

®, co-investigator Arvin K. George, MD, of Johns Hopkins Medicine, Baltimore, Maryland, explained how this technology has been replicated from what is currently being done in the management of benign prostatic hyperplasia (BPH) with Rezum treatment.

“It's essentially the same treatment modality, using steam or water vapor and using convection rather than conduction to be able to treat prostate cancer or prostate tissue,” George explained. “It has been redesigned to be able to perform the treatment directionally, meaning that we can get the water vapor or steam exactly where we want it within the prostate under image guidance or ultrasound MRI guidance.”

Francis Medical also noted that results from the VAPOR 2 trial will support a submission to the FDA for 510(k) clearance of the device. The company expects to file the application with the agency in July 2025.

1. Francis Medical announces completion of enrollment in the VAPOR 2 pivotal study for Vanquish prostate cancer treatment. News release. Francis Medical Inc. February 25, 2025. Accessed February 26, 2025. https://www.francismedical.com/completion-of-vapor-2-enrollment-for-vanquish-prostate-cancer-treatment/

2. Water vapor ablation for localized intermediate risk prostate cancer (VAPOR 2). ClinicalTrials.gov. Updated January 8, 2025. Accessed February 26, 2025. https://clinicaltrials.gov/study/NCT05683691

3. Francis Medical receives U.S. FDA Breakthrough Device Designation for Vanquish minimally invasive prostate cancer therapy. News release. Francis Medical Inc. August 1, 2023. Accessed February 26, 2025. https://www.francismedical.com/press-release-francis-medical-receives-fda-breakthrough-device-designation-for-vanquish/

The VAPOR 2 trial has successfully completed enrollment, assessing the Vanquish Water Vapor Ablation device for intermediate-risk, localized prostate cancer. The study enrolled 235 patients across 26 US sites, with all participants having completed initial treatment. The trial evaluates the device's safety and efficacy, with primary endpoints including freedom from systemic disease and urinary incontinence. The Vanquish device uses phase shift energy in water vapor to target cancerous tissue. Results will support an FDA 510(k) clearance application, expected in July 2025, with primary trial completion in April 2027.

Data from the VAPOR 2 trial are intended to support a submission to the FDA for 510(k) clearance of the device.

Enrollment goal met in trial of Vanquish device for localized prostate cancer

Standard of Care and Intravesical Chemotherapy in NMIBC

How do you use guidelines to treat patients with NMIBC?

Where are you using intravesical chemotherapy in your patients with NIMBC?

Experts discuss the standard of care and the use of intravesical chemotherapy in the treatment of non–muscle-invasive bladder cancer (NMIBC).

Panelists examine disease heterogeneity in NMIBC and discuss a balanced treatment approach that prioritizes patient quality of life and surgery effectiveness.

Episode 3 Podcast: Treatment Strategies to Tackle NMIBC Heterogeneity

Panelists discuss the impact of long-term care in patients with non–muscle-invasive bladder cancer (NMIBC), considering the unique needs of specific patient groups and highlighting advancements in NMIBC treatment that may support better care experiences for patients.

Matthew R. Cooperberg, MD, MPH

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