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“The data presented at EAU25 add to the growing body of evidence supporting the CVAC System as the emerging standard of care in kidney stone removal,” says Brett Johnson, MD. 

CVAC2 shows safety, efficacy for stone clearance in real-world study

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

FDA updates in urology: March 2025

"I think a take-home message there is that in the prostate/prostate bed, you have to take extra time and caution in reading that region," says Phillip H. Kuo, MD, PhD.

18F-flotufolastat PET/CT shows high inter- and intrareader agreement rates 

The European Commission must issue a decision on the application on or by June 2, 2025.

Subcutaneous nivolumab under review in EU for solid tumors

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Authors

Smigelski is a chief resident at NewYork-Presbyterian/Columbia University Irving Medical Center, New York, New York.

Growing evidence supports the existence of an intermediate metastatic disease state.

Management of hormone-naïve oligometastatic prostate cancer

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 policy environment surrounding telehealth is a volatile one, according to 

. While legislators have made several decisions to extend telehealth flexibilities that were implemented during the COVID-19 pandemic, they have failed to pass any language to secure its permanent coverage.

Given this uncertainty, urologists and other health care professionals may feel unsure on how to incorporate telehealth in their practice. After all, Congress must decide on telehealth’s future yet again by the end of September, or else these provisions will expire.

®, Ellimoottil offered reassuring advice to urologists who are unsure of how to approach telehealth in this shaky environment: continue with the mindset of business as usual. 

Chad Ellimoottil, MD, MS, offered reassuring advice to urologists who are unsure of how to approach telehealth in this shaky environment.

Chad Ellimoottil, MD, on how urologists should approach telehealth in changing policy environment

According to Ellimoottil, there is large support to continue coverage of telehealth flexibilities into the future, which make him optimistic about the potential for permanent coverage.

“People have seen the benefits of telehealth [and] practices have seen the benefits of telehealth over the last 4 years,” he said. “Folks do want to keep it the same. I think that it's very non-controversial from that standpoint.”

However, there are some areas of dissension, he explained.

“The areas where there is a little bit more debate are around how to create guardrails, or how to make sure that there's not a lot of fraud and abuse, so that's where the attention is. Fortunately, there [have] been big studies like from the Office of Inspector General that have found very little fraud and abuse among telehealth providers like us.”

Data such as these will help to inform telehealth's future.

"I say with a lot of confidence, just continue using telehealth as you are," says Chad Ellimoottil, MD, MS.

In a recent long-term, multicenter analysis of patients undergoing robot-assisted radical cystectomy (RARC), the 12-year overall survival for the entire cohort was 49%, whereas the cancer-specific survival was 76%.

®, study author Neeraja Tillu, MD, said, “Given that many patients in this cohort have a history of long-term smoking, they frequently present with significant comorbid conditions, such as cardiovascular disease, pulmonary disorders, and other smoking-related illnesses. Consequently, the difference between overall survival and cancer-specific survival reflects a substantial impact of these non-bladder-related causes.”

Tillu, a urologic oncology fellow at Icahn School of Medicine at Mount Sinai in New York, New York, outlined the surveillance protocol recommended for patients defined as upstage: “regular…lab tests, urine cytology, and we do imaging every year to detect any distant or local recurrences at an early stage.

“For the non-upstage group, although oncological follow-up remains important, there is an emphasis placed on comprehensive health monitoring to address and manage non-cancer-related comorbidities proactively,” Tillu added.

Neeraja Tillu, MD, discusses study findings in a group of patients undergoing RARC for bladder cancer

What a long-term study of patients undergoing RARC reveals about upstaging

Tillu and her coauthors also found that a body mass index of at least 28 kg/m² reduced upstaging. When asked about this finding, Tillu said, “Our finding that higher BMI…is associated with reduced upstaging was an unexpected result, and this could reflect better nutritional status or metabolic differences, but confounding factors like selection bias, since it's a retrospective study, comorbid conditions and differential health care access should be considered. This does not directly influence our clinical management, although it does highlight the importance of comprehensive patient health optimization.”

Tillu said the take-home message of the study is, “High risk, non–muscle invasive bladder cancer carries a significant risk of recurrence and progression. This emphasizes the need for careful patient selection, especially when we are considering bladder-sparing approaches. Our study also revealed a notable incidence of pathological upstanding. Almost a third of our patients were upstaged, which highlights the limitations of current imaging modalities, and underscores the urgency for improved diagnostic techniques such as MRI with the PI-RADS system to accurately identify muscle-invasive disease at diagnosis. Practicing urologists should proactively discuss the option of upfront radical cystectomy in patients who exhibit high-risk features rather than relying solely on intravesical therapies to optimize oncological outcome.”

1. Tillu N, Ben-David R, Skokic V, et al. Long-term multicentre analysis of robot-assisted radical cystectomy for non-muscle-invasive bladder cancer. 

“High risk, non–muscle invasive bladder cancer carries a significant risk of recurrence and progression. This emphasizes the need for careful patient selection, especially when we are considering bladder-sparing approaches," says Neeraja Tillu, MD.

Today, March 28, 2025, the FDA granted de novo marketing clearance to Visby Medical Women’s Sexual Health Test for the detection of sexually transmitted infections (STIs) caused by 

The at-home test can deliver diagnostic results in approximately 30 minutes. According to the FDA, this is the first approved diagnostic test for chlamydia, gonorrhea, and trichomoniasis that can be purchased without a prescription and used at home.

The test was previously granted 510(k) clearance and a CLIA waiver for point-of-care administration during patient visits.

“Home tests can give people information about their health from the privacy of their home. This can be particularly important for sexual health tests for which patients may experience fear or anxiety, possibly resulting in delayed diagnosis or treatment,” explained Courtney H. Lias, PhD, director of the Office of In Vitro Diagnostic Devices in the FDA’s Center for Devices and Radiological Health, in the news release.

 “Expanding access to tests for sexually transmitted infections is an important step toward earlier and increased diagnosis, which can result in increased treatment and reduced spread of infection.”

According to the FDA, “The Visby Medical Women’s Sexual Health Test is a single-use, at-home test, that includes a collection kit (self-collected vaginal swab) and a powered testing device, which communicates securely to the Visby Medical App, which displays results when the test is complete.”

No separate instrument or reader is needed, according to Visby Medical.

The authorization was supported by data from a study that included women with and without symptoms. In assessing for 

, the test was able to correctly identify 98.8% of negative samples and 97.2% of positive samples. In assessing for 

, the test correctly identified 99.1% of negative samples and 100% of positive samples. The test also detected 98.5% of true negative and 97.8% of true positive 

According to the FDA, the main risks associated with this test include the possibility of false negative and false positive results, similar to other diagnostic tests.

The agency explained, “False negative test results can result in delays to effective treatment and spread of infection to other persons. False positive results could lead to unnecessary treatment and/or a delay in receiving a correct diagnosis and appropriate treatment.”

The test was approved through the FDA’s de novo premarket review pathway, which is intended for novel devices with a low- to moderate-risk.

They added, “Today’s action also opens the 510(k) pathway for other home tests for sexually transmitted infections.”

1. FDA grants Marketing Authorization of first home test for chlamydia, gonorrhea and trichomoniasis. News release. US Food & Drug Administration. Published online and accessed March 28, 2025. https://www.fda.gov/news-events/press-announcements/fda-grants-marketing-authorization-first-home-test-chlamydia-gonorrhea-and-trichomoniasis

2. Visby Medical receives FDA clearance and CLIA waiver at the point of care for PCR Sexual Health Test. News release. Visby Medical. August 30, 2021. Accessed March 28, 2025. https://www.visbymedical.com/news/visby-medical-receives-fda-clearance-and-clia-waiver-at-the-point-of-care-for-pcr-sexual-health-test/

3. Sexual Health Test. Visby Medical. Accessed March 28, 2025. https://www.visbymedical.com/sexual-health-test/

The FDA has granted de novo marketing clearance for the Visby Medical Women’s Sexual Health Test, an at-home diagnostic tool for detecting STIs such as chlamydia, gonorrhea, and trichomoniasis. This test, which provides results in about 30 minutes, is the first of its kind available without a prescription. It includes a self-collected vaginal swab and a powered testing device that communicates results via an app. The test demonstrated high sensitivity and specificity in clinical studies, though risks of false results remain.

The test can deliver diagnostic results for chlamydia, gonorrhea, and trichomoniasis.

FDA grants marketing authorization to at-home diagnostic test for STIs

’® monthly FDA update! This month, key developments include advances in prostate and kidney cancer detection, as well as an emerging treatment option in primary hyperoxaluria 1 (PH1).

Stay informed with our FDA recap, delivered during the first week of each new month. To stay even more informed on the latest from 

FDA awards orphan drug, rare pediatric disease designations to ABO-101 for PH1

On February 5, 2025, Arbor Biotechnologies announced that the FDA granted orphan drug and rare pediatric disease designations to the investigational gene editing therapy ABO-101 for the treatment of patients with primary hyperoxaluria type 1 (PH1). Preclinical studies showed ABO-101’s ability to target the 

 gene, reduce oxalate production, and preserve genomic integrity in non-human primates. The company plans to initiate the phase 1/2 redePHine trial in the first half of 2025 to evaluate the therapy’s safety and efficacy in patients with PH1.

FDA grants 510(k) clearance to AI-powered prostate cancer diagnostic

On February 10, 2025, Ibex Medical Analytics announced FDA 510(k) clearance for Ibex Prostate Detect, an AI-powered digital pathology software for detecting prostate cancer in tissue biopsies. This decision was based on validation studies showing a 99.6% positive predictive value for heatmap accuracy, as well as data showing that pathologists diagnosing without AI missed 13% of the cancer cases that were identified by the AI. This marks Ibex’s first FDA clearance, and the company is hoping that the clearance will bolster adoption of AI-powered digital pathology in clinical practice.

On February 19, 2025, Clarity Pharmaceuticals announced that the FDA granted fast track designation to 

Cu-SAR-bisPSMA for the treatment of patients with PSMA-positive metastatic castration-resistant prostate cancer who were previously treated with an androgen receptor pathway inhibitor. This designation is supported by preliminary data from the ongoing phase 1/2a SECuRE trial (NCT04868604), which has shown promising prostate-specific antigen reductions and manageable safety in heavily pretreated patients. The designation enables Clarity to expedite development, with the trial now evaluating multi-dose regimens and potential combination therapy with enzalutamide.

Zr-DFO-girentuximab for kidney cancer imaging

On February 25, 2025, Telix Pharmaceuticals announced that the FDA accepted and granted priority review to a biologics license application (BLA) for 

Zr-DFO-girentuximab (Zircaix) for PET imaging of clear cell renal cell carcinoma (ccRCC). The BLA is backed by data from the phase 3 ZIRCON trial, which demonstrated high sensitivity (85.5%) and specificity (87%) in detecting ccRCC in patients with an indeterminate renal mass. The FDA has set a PDUFA target action date of August 27, 2025 for the application.

FDA issues labeling changes for testosterone products following TRAVERSE, postmarket studies

On February 28, 2025, the FDA announced class-wide labeling changes for testosterone products based on findings from post-market ambulatory blood pressure monitoring studies and the TRAVERSE trial. Specifically, the FDA is requiring a warning on increased blood pressure and is recommending the removal of the black box warning regarding an increased risk of adverse cardiovascular outcomes. These updates clarify prior safety concerns and may facilitate more informed discussions between patients and providers about testosterone therapy.

February 2025 saw significant FDA developments in urology, including orphan drug and rare pediatric disease designations for ABO-101, a gene editing therapy for primary hyperoxaluria type 1 (PH1). Ibex Medical Analytics received 510(k) clearance for an AI-powered prostate cancer diagnostic tool, enhancing detection accuracy. Clarity Pharmaceuticals' 67Cu-SAR-bisPSMA for metastatic castration-resistant prostate cancer gained fast track designation, expediting its development. Additionally, Telix Pharmaceuticals' 89Zr-DFO-girentuximab for kidney cancer imaging received priority review, with a PDUFA target action date set for August 27, 2025.

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

Michael Smigelski, MD

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