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"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

The approval is supported by results from the phase 3 NIAGARA trial.

FDA approves durvalumab/chemo for muscle–invasive bladder cancer

The approval is supported by positive data from the phase 3 PSMAfore trial.

FDA approves expanded label for 177Lu-PSMA-617 in mCRPC

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"Despite the uncertain times, I am grateful to be a student in the field of medicine, where compassion is one of the traits that defines its practitioners," says PA student Steffanie Robertus.

When it comes to urology teaching or learning opportunities, just say yes

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

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. 

FDA updates in urology: February 2025

Today, March 28, 2025, the FDA approved neoadjuvant durvalumab (Imfinzi) in combination with gemcitabine and cisplatin, followed by adjuvant durvalumab monotherapy following radical cystectomy, for adult patients with muscle invasive bladder cancer (MIBC).

“This approval for the durvalumab-based perioperative regimen is a major breakthrough for people with muscle-invasive bladder cancer, nearly half of whom see their cancer return despite chemotherapy and surgery with curative-intent," said Matthew D. Galsky, MD, of the Icahn School of Medicine at Mount Sinai in New York, in a news release.

 "This durvalumab regimen significantly extended patients’ lives in the NIAGARA trial and has the potential to transform care.”

The approval is supported by results from the phase 3 NIAGARA trial (NCT03732677), which showed that perioperative durvalumab plus neoadjuvant chemotherapy extended event-free survival (EFS) and overall survival (OS) vs neoadjuvant chemotherapy alone.

At 24 months, the estimated EFS was 67.8% (95% CI, 63.6 to 71.7) in the durvalumab arm vs 59.8% (95% CI, 55.4 to 64.0) in the control arm (HR, 0.68; 95% CI, 0.56 to 0.82; 

 < .001). The median EFS was not reached in the durvalumab arm and was 46.1 months (95% CI: 32.2, NR) in the chemotherapy arm. At a median follow-up of 42.3 months, 35.1% of patients in the durvalumab arm and 46.4% of patients in the control arm experienced an EFS event.

The estimated 24-month OS was 82.2% (95% CI, 78.7 to 85.2) in the durvalumab arm vs 75.2% (95% CI, 71.3 to 78.8) in the control arm (HR, 0.75; 95% CI, 0.59 to 0.93; 

 = .01). The median OS was not reached in either arm.

Pathological complete response (pCR), the trial’s second primary end point, was not significantly different between both arms. Specifically, the pCR rate was 33.8% (95% confidence interval [CI], 29.8 to 38.0) in the durvalumab arm vs 25.8% (95% CI, 22.2 to 29.8) in the control arm (RR, 1.30; 95% CI, 1.09 to 1.56; 

Regarding safety, adverse events (AEs) were comparable between both arms.

Grade 3-4 AEs occurred in 69.4% of patients I nthe durvalumab arm and 67.5% of patients in the control arm. Grade 3-4 treatment-related AEs were reported in 40.6% and 40.9% of patients, respectively.

The authors also reported, “Radical cystectomy was performed in 88.0% of the patients in the durvalumab group and in 83.2% of those in the comparison group.”

In total, the open-label NIAGARA trial enrolled 1063 adult patients with cisplatin-eligible MIBC who were candidates for radical cystectomy and had not received prior systemic therapy for bladder cancer. Participants were randomly assigned 1:1 to receive neoadjuvant durvalumab plus gemcitabine-cisplatin every 3 weeks for 4 cycles followed by radical cystectomy and adjuvant durvalumab every 4 weeks for 8 cycles (n = 533) or to receive neoadjuvant gemcitabine-cisplatin followed by radical cystectomy alone (n = 530).

The dual primary end points were EFS and pathological complete response. OS was a key secondary end point.

In the news release on the approval, the FDA advised, "The recommended durvalumab dose for patients with a body weight of 30 kg [or greater] is 1,500 mg every 3 weeks with chemotherapy (neoadjuvant treatment) and 1,500 mg as a single agent every 4 weeks (adjuvant treatment). The recommended durvalumab dose for patients with a body weight [less than] 30 kg is 20 mg/kg with chemotherapy every 3 weeks (neoadjuvant treatment) and 20 mg/kg as a single agent every 4 weeks (adjuvant treatment). Treatment should continue until disease progression that precludes definitive surgery, recurrence, or unacceptable toxicity or a maximum of 8 cycles after surgery."


1. 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

2. IMFINZI (durvalumab) approved in the US as first and only perioperative immunotherapy for patients with muscle-invasive bladder cancer. News release. AstraZeneca. Published online and accessed March 31, 2025. https://www.astrazeneca-us.com/media/press-releases/2025/IMFINZI-durvalumab-approved-in-the-US-as-first-and-only-perioperative-immunotherapy-for-patients-with-muscle-invasive-bladder-cancer.html

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

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

The FDA has approved the use of neoadjuvant durvalumab in combination with gemcitabine and cisplatin, followed by durvalumab alone as adjuvant therapy, for adults with muscle invasive bladder cancer (MIBC) post-radical cystectomy. This decision is based on the phase 3 NIAGARA trial, which demonstrated that the combination therapy significantly improved event-free survival (EFS) and overall survival (OS) compared to chemotherapy alone. The approval marks a significant advancement in the treatment options available for MIBC, offering a new therapeutic strategy to enhance patient outcomes.

Real-world data indicate a significantly lower incidence of all-cause bowel disorders in patients with prostate cancer who received radiotherapy treatment along with placement of a polyethylene glycol-based hydrogel spacer (spaceOAR) vs patients who did not receive a spacer.

®, Michael R. Folkert, MD, PhD, explained, “What we were doing with this study is we were trying to look at real-world data for spacer use. We have a lot of prospective data to guide us in in our care of patients, but it's nice to see what happens when you actually apply it to real patients.” Folkert is a professor of radiation oncology at the University of Washington School of Medicine, Seattle.

For the study, Folkert and his colleagues evaluated data on patients from 4 separate data sets: Medicare 5% Standard Analytic Files, Medicare 100% Standard Analytic Files, Merative MarketScan Commercial Database, and Premier Healthcare Database. Patients with prostate cancer who were treated with radiotherapy between 2015 and 2021 were included in the analysis.

“From those data sets, we were able to extract a range of codes for disorders and procedures that were related to bowel complaints to bowel disorders, and then conducted an analysis to probe associations between these codes and the use of rectal spacers, and then a comparison also of disorders and procedures the same sets of disorders and procedures related to bowel complaints and disorders on an age-matched general population that didn't have prostate cancer, to kind of ground the that experience in a general population,” Folkert said.

Regarding their findings, “4 years following radiation therapy, there is a 25% lower hazard of bowel disorders and a 46% lower hazard of related procedures [in patients who received a spacer],” Folkert said.  

1. Folkert MR, Sato R, Yu JB, et al. Bowel disorder incidence and rectal spacer use in patients with prostate cancer undergoing radiotherapy. 

. 2025;8(3):e250491. doi:10.1001/jamanetworkopen.2025.0491

A study evaluated the impact of polyethylene glycol-based hydrogel spacers on bowel disorder incidence in prostate cancer patients undergoing radiotherapy. Using real-world data from multiple databases, researchers found that patients with spacers experienced significantly lower rates of bowel disorders and related procedures compared to those without spacers. Specifically, there was a 25% reduction in the hazard of bowel disorders and a 46% reduction in related procedures four years post-radiotherapy. This study highlights the potential benefits of spacer use in reducing bowel complications in prostate cancer treatment.

"4 years following radiation therapy, there is a 25% lower hazard of bowel disorders and a 46% lower hazard of related procedures [in patients who received a spacer],” says Michael R. Folkert, MD, PhD.

Steffanie Robertus

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