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Articles

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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Clinical

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Clinical Focus

2025 GU Satellite Symposia in San Francisco

"At ASCO GU, we presented the final analysis of the study, which confirmed the superiority of a combination over the TKI monotherapy in terms of both progression-free survival as well as overall survival," says Camillo Porta, MD. 

Camillo Porta, MD, offers key takeaways from CheckMate 9ER trial in renal cell carcinoma

Robert J. Motzer, MD, reported that median PFS was 16.4 months in the nivolumab plus cabozantinib arm (95% CI, 12.5-19.3) vs 8.3 months in the sunitinib arm (95% CI, 7.0-9.7) (HR=0.58, 95% CI, 0.49-0.70). 

Final CheckMate 9ER data show long-term efficacy of nivolumab/cabozantinib in RCC

The conditional approval of belzutifan is valid for 1 year, with the opportunity for yearly renewal pending forthcoming data.

Belzutifan approved in EU for renal cell carcinoma

“Over 80% of patients…had at least 2 lines of therapy, so this is a heavily refractory population,” said Toni K. Choueiri, MD, FASCO. 

Casdatifan is linked with promising safety, efficacy in clear cell RCC

Francesca Jackson-Spence, MBChB, BMedSc, MRCP, highlights the ongoing phase 3 SAMETA trial (NCT05043090) in MET-driven locally advanced or metastatic papillary renal cell carcinoma. 

Francesca Jackson-Spence, MBChB, details the ongoing SAMETA trial in papillary renal cancer

Francesca Jackson-Spence,MBChB, BMedSc, MRCP, 

highlights the ongoing phase 3 SAMETA trial (NCT05043090) in MET-driven locally advanced or metastatic papillary renal cell carcinoma. The trial was initiated based on findings from the study, “Final overall survival and new ctDNA analysis in MET-driven advanced papillary renal cancer (CALYPSO; NCT02819596),” which was presented at the 

2025 American Society of Clinical Oncology Genitourinary Cancers Symposium

Jackson-Spence is a clinical research fellow in genitourinary oncology at Barts Cancer Institute, Queen Mary’s University in London.

SAMETA is an open-label randomized phase 3 study. It has 3 arms. It's comparing the savolitinib and durvalumab combination, durvalumab monotherapy, and sunitinib monotherapy. It's completed its enrollment; we've recruited around 200 patients globally. The study is conducted in that MET-driven subset, so patients with advanced papillary renal cancer that have MET-driven tumors. The primary end point is progression-free survival, and the secondary end points are overall survival, objective response rates, duration of response, and safety.

This transcript was AI generated and edited by human editors for clarity.

Videos

“The primary end point is progression-free survival, and the secondary end points are overall survival, objective response rates, duration of response, and safety.”

Kate H. Gessner, MD, PhD, discusses when to switch to a different systemic agent vs metastasis-directed therapy (MDT) following failure of immunotherapy in metastatic renal cell carcinoma.

Kate Gessner, MD, on systemic agents vs MDT after kidney cancer progression

, discusses when to switch to a different systemic agent vs metastasis-directed therapy (MDT) following failure of immunotherapy in metastatic renal cell carcinoma. Gessner took part in the discussion, “Case-Based Session: Failure of Immunotherapy in Renal Cell Cancer—What’s Next?” at the 

2025 American Society of Clinical Oncology Genitourinary (ASCO GU) Cancers Symposium

Gessner is an associate professor of urology at the University of North Carolina School of Medicine in Chapel Hill.

When we're deciding whether to switch to different systemic agents or to consider metastasis-directed therapy, we're really taking the whole clinical picture into account. Dr. Maria Bourlon today will talk about oligoprogression vs widespread metastatic progression. In the setting of oligoprogression, you can consider more of a metastasis-directed therapy, such as in the form of radiation therapy, which Dr. Raquibul Hannan and Dr. Leslie Ballas will talk about today. In that setting, in oligoprogression, radiation therapy to metastatic sites can extend progression-free survival. However, in the setting of widespread metastatic progression or failure, then we typically prefer more systemic therapy with metastasis-directed therapy for symptomatic sites.

“In the setting of widespread metastatic progression or failure, we typically prefer more systemic therapy with metastasis-directed therapy for symptomatic sites,” says Kate H. Gessner, MD, PhD.

Taylor Goodstein, MD, highlights an ongoing research project on the rates of upstaging and downstaging in larger kidney tumors

Taylor Goodstein, MD, highlights project on staging in larger kidney tumors

, highlights an ongoing research project on the rates of upstaging and downstaging in larger kidney tumors. Goodstein is an SUO fellow at Emory Urology in Atlanta, Georgia.

There's a study I'm working on right now. I'm actually working with one of my colleagues back at Ohio State. I started on this project when I was still there, with Dr. Eric Singer as the PI. What we're looking at is the upstaging of kidney tumors. The reason why we started asking that question [is that] kidney tumor upstaging has always been reported for smaller stage 1 tumors, because it might change your management from partial to radical nephrectomy, but there hasn't really been a need to know what the upstaging is between these larger tumors to more invasive tumors. Except for now we've got these perioperative trials that are happening, like the PROSPER-RCC trial (NCT03055013), which looked at giving a dose of nivolumab prior to doing a nephrectomy and then following with another short course of nivolumab. Ultimately, it was a negative study, but it required them to actually clinically stage patients for inclusion in that trial. When it came out as a negative study, there was a lot of questions. Why was it a negative study?

One of the big concerns was did we choose the right cohort of patients? These were clinically staged patients. How accurate was that clinical staging? If you look at the table of that trial, there was a significant amount of upstaging and even some downstaging that happened from their clinical to pathological stage. What we've been working on is a giant 30,000 patient database study using the National Cancer Database to see exactly what the rates are of upstaging and downstaging for these larger kidney tumors, and then taking that a step further and trying to see if there's a survival difference if the patient was upstaged or downstaged or not. So, I don't think anybody's really looked too much at that before. I'd say that's something that we're doing that's pretty novel.

“What we've been working on is a giant 30,000 patient database study using the National Cancer Database to see exactly what the rates are of upstaging and downstaging for these larger kidney tumors,” says Taylor Goodstein, MD. 

Tang discusses the limitations in available data, but nonetheless high potential, of SBRT in kidney cancer.

Chad Tang, MD: Considerations for SBRT in metastatic RCC

American Society for Radiation Oncology (ASTRO) 2024 Annual Meeting

 in Washington DC, this month, Chad Tang, MD, of the department of GU Radiation Oncology at the MD Anderson Cancer Center, discussed the utility of stereotactic body radiation therapy (SBRT) in the treatment of patients with metastatic 

As Tang noted in his ASTRO 2024 presentation topic, SBRT has been linked to significantly high rates of patients achieving progression-free survival, even without systemic therapy, for kidney cancer over about the span of a year now—though more research needs to inform the promising early evidence.

“There’s no high-level data, there’s no phase 3 randomized trials comparing these different strategies for both oligometastatic and oligo-progressive (RCC),” Tang said. “Another area I would want to highlight is that there’s a big gap in treating the primary in patients with metastatic disease.”

Regardless, SBRT’s position as an option to spare use of systemic therapy or possibly even change patients’ natural history is not being undone by any more recent study findings.

“And as we all know, (RCC) can be quite indolent sometimes,” Tang said. “We know it can be quite heterogeneous sometimes in terms of its genetic makeup, and sometimes one site just has a different evolution and it progresses while on IO/IO and IO/TKIO, and we can control that.”

Regarding the clinician-patient discussion around SBRT to treat metastatic RCC, Tang recommended his colleagues practice frankness around the level of available data supporting the treatment strategy—especially based on the patient’s age.

“In my experience, a lot of younger patients want the kitchen sink thrown at them for any possible benefit,” Tang said. “You have to be frank about, 'We can do this, but the level of evidence is thus, and not robust usually.' But usually, we also say that a lot of these techniques that we've done, the side effect profile is relatively modest.”

Stereotactic body radiation therapy (SBRT) is emerging as a promising treatment for metastatic renal cell carcinoma (RCC), potentially offering progression-free survival without systemic therapy. Despite the lack of high-level data or phase 3 trials, SBRT remains a viable option, especially for oligometastatic and oligo-progressive RCC. The treatment's efficacy may vary due to RCC's genetic heterogeneity. Clinicians are advised to discuss the limited evidence supporting SBRT with patients, particularly younger ones, while noting its relatively modest side effect profile.

News

Zaorsky discusses the patient safety misconceptions around radiotherapy for RCC, and considering patient-reported outcomes in future randomized controlled trials.

Considering patient-reported outcomes in kidney cancer care, with Nicholas Zaorsky, MD, PhD

 in Washington, DC, showed stereotactic body radiotherapy (SBRT), along with partial nephrectomies and ablative therapies, are less likely to impact longterm kidney function versus radical nephrectomy in patients with localized 

The findings, presented by study author Nicholas Zaorsky, MD, MS, of the University Hospitals Case Medical Center, may shine a light on a prevalent misconception regarding the risks of stereotactic radiation for clinicians outside of radiation oncology.

In the second segment of an interview with 

 Zaorsky discussed the greater takeaways of his team’s research—namely the observed low toxicity rate associated with radiation therapy for RCC. The findings buck against major trends of care for kidney cancer.

“Our research specifically looked at the trying to quantify renal function, and trying to quantify how much are the kidneys impacted by this treatment, and how do we best go forward in looking at minimizing the impact on the kidneys while hopefully still maintaining patient quality of life,” Zaorsky said. “If you look at the National Cancer database, which is the US database that looks at the treatments that are used for cancer, about 90% of patients currently receive some form of surgery for their kidney cancer.“

Zaorsky additionally discussed the prospect of advancing the findings of these analyses toward a randomized controlled trial that specifically considered patient-reported quality of life outcomes associated with different RCC treatment modalities—outcomes generally not considered in the initiation and follow-through of kidney cancer therapy.

“If we want to increase the use of something like radiation therapy, or build a randomized controlled trial that compares the treatments—or even get the patients an opinion about radiation therapy—I think that it's critical for the patients to be discussed at multidisciplinary tumor boards and to have that patient see multiple physicians,” Zaorsky said. “It's also important to note that radiation therapy is already listed in the NCCN guidelines as a category 1 recommendation for many patients, and so I think it's very reasonable for surgeons and for oncologists to have to basically automatically refer patients once they're diagnosed to have them meet with a radiation oncologist.”

Rajoulh C, Ali M, Wang M, Siva S et al. Renal Function after Definitive Local Therapy for Primary Renal Cell Carcinoma: A Meta-Analysis. Poster presented at: American Society for Radiation Oncology (ASTRO) 2024 Annual Meeting. Washington, DC. September 29 – October 2, 2024.

Kunzmann K. Nicholas Zaorsky, MD, MS: Protecting kidney function after local renal cell carcinoma therapy. 

. Published October 1, 2024. https://www.urologytimes.com/view/nicholas-zaorsky-md-ms-protecting-kidney-function-after-local-renal-cell-carcinoma-therapy

Zaorsky discusses his team's ASTRO 2024 abstract showing clear benefit of radiotherapy and ablation in reduced kidney effects in patients with RCC.

 Nicholas Zaorsky, MD, MS: Protecting kidney function after local renal cell carcinoma therapy

Stereotactic body radiotherapy (SBRT), partial nephrectomy (PN), and ablative therapies are linked to less harmful effects on kidney function among the options for localized 

 in Washington, DC, this week showed SBRT, PN and ablation were linked to lesser declines in estimated glomerular filtration rate (eGFR) versus radical nephrectomy (RN) among patients treated for RCC. Investigators additionally observed the fewest rates of grade ≥3 toxicities with SABR treatment compared to the other local therapy options.

Presented by investigator Nicholas Zaorsky, MD, MS, of the University Hospitals Case Medical Center, investigators believe the findings could help inform patient-tailored care conversations around long-term RCC management. The systematic review and meta-analysis may also help inform future clinical trials assessing disparities in local RCC therapy options.

 during ASTRO 2024, Zaorsky discussed the significance of his team’s findings—particularly at a time when kidney cancer diagnoses have increased dramatically due to innovation in cross-section imaging. With this rise of new cases, there have been more datapoints to observe the effect of the 3 pathways of treatment: nephrectomies, ablations, and radiation.

“We know that there are no randomized studies out there that compare them head-to-head—there's no prospective trial that has compared treatment 1 versus 2, etc.," Zaorsky said. "And we know at the same time that each of these treatments can affect kidney function.”

Their meta-analysis findings confirmed that radiation therapy, specifically SBRT, may provide the best combination of preserved renal function and significantly lowered toxicity rates among all the observed treatment arms.

“This, in combination with the results of trials that have been presented and published within the past few years from the IROC consortium—where we see that the cancer control rate is above 95% or close to 100%—we think that radiation therapy is one of the best treatment options available for kidney cancer,” Zaorsky said. “And so, we hope that this study can help guide discussions among physicians and patients, in terms of selecting the best treatment option, and it can also help to guide a randomized, controlled trial—and powering the trial appropriately, so that we can get some prospective data to compare the different treatments.”

Toni K. Choueiri, MD, shares the background and key findings from the study, “Tivozanib–nivolumab vs tivozanib monotherapy in patients with renal cell carcinoma (RCC) following 1 or 2 prior therapies including an immune checkpoint inhibitor (ICI): Results of the phase III TiNivo-2 study,”

Toni K. Choueiri, MD, on key takeaways from TiNivo-2 trial 

, shares the background and key findings from the study, “Tivozanib–nivolumab vs tivozanib monotherapy in patients with renal cell carcinoma (RCC) following 1 or 2 prior therapies including an immune checkpoint inhibitor (ICI): Results of the phase III TiNivo-2 study,” which was presented at the 2024 

European Society for Medical Oncology Annual Congress

 in Barcelona, Spain. Choueiri is the director of the Lack Center for Genitourinary Oncology at Dana-Farber Cancer Institute in Boston, Massachusetts.

The TiNivo-2 trial was a phase 3 study that asked the question of immune checkpoint blockers, PD-1, PD-L1 inhibitor, rechallenge in metastatic renal cell cancer. The design included a TKI, tivozanib, in both arms and then adding nivolumab, a PD-1 inhibitor. Again, patients should have had experienced disease progression on prior PD-1 inhibitor. This is a soaring question in the field of kidney cancer and in solid tumors in general. I don't think this was asked. We had a study last year that showed adding atezolizumab as a rechallenge to a TKI does not at all improve clinical outcomes. But here the difference [is] that we have a PD-1 inhibitor, and the last therapy was not always an immune checkpoint inhibitor. 

So, the study was dead negative. PFS, OS, [and] response rate were similar in both arms. Though I would say also that the dose in the combination arm of tivozanib was lower because of earlier studies showing increased risk of grade 3/4 hypertension. Again, this is the second study of ICI, immune checkpoint inhibitor, rechallenge, both published in The Lancet 1 year apart. [They] showed that re-challenging, at least, I would say in metastatic RCC with an immune checkpoint inhibitor, should be discouraged outside some specific situations, such as a long duration from prior immune checkpoint inhibitor–the patients that were not included in TiNivo-2.

This transcription has been edited for clarity. 

The TiNivo-2 trial demonstrated that rechallenging ICI therapy does not improve outcomes in patients with renal cell carcinoma.

Dr. Toni Choueiri on key takeaways from TiNivo-2 trial 

Eric Jonasch, MD, discusses next steps and potential implications of findings from an ongoing phase 1/2 study of the investigational oral HIF-2α inhibitor NKT2152

ESMO 2024: Dr. Jonasch on implications of positive HIF-2α inhibitor data in ccRCC

, discusses next steps and potential implications of findings from an ongoing phase 1/2 study (NCT05119335) of the investigational oral HIF-2α inhibitor NKT2152, which were presented at the 2024 European Society for Medical Oncology Annual Congress in Barcelona, Spain. Overall, 

 that NKT2152 demonstrated strong anti-tumor activity in patients with heavily pretreated advanced clear cell renal cell carcinoma.

Jonasch is a professor of genitourinary medical oncology at the University of Texas MD Anderson Cancer Center in Houston.

What are the next steps for this agent based on these findings?

It's clear this agent is active. The question now really would be, what would be an appropriate registrational strategy to move this agent forward as a potential treatment for patients with renal cell carcinoma? That's a matter of discussion at this point in time by the company, and they're going to be deciding on how to move forward.

What are the potential clinical implications of this research?

It clearly shows that blocking HIF-2α is a meaningful way of interacting with disease biology in clear cell renal cell carcinoma. It may be good to have more than 1 agent of the same class. We clearly need to learn much more though about which patients are most likely to respond, why does resistance occur, and what would be the best partners in terms of combination strategies for this agent.

This transcription has been edited for clarity.

"It clearly shows that blocking HIF-2α is a meaningful way of interacting with disease biology in clear cell renal cell carcinoma," says Eric Jonasch, MD.  

Dr. Fallah on “Cytoreductive nephrectomy in the era of immune checkpoint inhibitors: a U.S. FDA pooled analysis.”

Expert discusses pooled analysis of cytoreductive nephrectomy

 paper, “Cytoreductive nephrectomy in the era of immune checkpoint inhibitors: a U.S. FDA pooled analysis.” Fallah is a medical oncologist with the FDA.

How do the treatments in the study compare to patients with metastatic kidney cancer today?

As I mentioned earlier, we did not include the trial of ipilimumab and nivolumab in this analysis, and the combination of atezolizumab and bevacizumab that we included in the pool has not been approved for treatment of RCC. However, the other 4 trials that were included in this pooled analysis led to FDA approval of the investigative combinations of immune checkpoint inhibitor and VEGF TKI.

Within the confines of the limitations, are there certain patients for whom the study suggests would benefit most from CN over others?

We may be tempted to conclude a causal relationship based on the results of this analysis; however, we should avoid making statements implying a causal relationship. For example, we cannot say that cytoreductive nephrectomy improves patient outcomes, and we cannot conclude it provides any benefit in this setting. Our analysis only demonstrated an association, which may be due to the effects of nephrectomy or confounding factors associated with patient selection for nephrectomy, or both. And to answer this question, we need a randomized trial.

This transcription was edited for clarity.

“We may be tempted to conclude a causal relationship based on the results of this analysis; however, we should avoid making statements implying a causal relationship,” says Jaleh Fallah, MD.

Dr. Fallah on “Cytoreductive nephrectomy in the era of immune checkpoint inhibitors: a U.S. FDA pooled analysis.” 

Dr. Fallah on limitations of pooled analysis of cytoreductive nephrectomy

What are the major limitations of the pooled analysis?

Our pooled analysis had a couple of limitations. It was a retrospective analysis, and there were variations across trials in terms of previously collected information. For example, the studies did not indicate if nephrectomy was conducted with curative or cytoreductive intent. And the date of nephrectomy was not available in many of the cases. So, we only included patients who had metastatic disease at diagnosis in whom the indication for nephrectomy would be cytoreduction. This did not allow us to include studies that did not provide this information, such as Checkmate 214, which evaluated ipilimumab [Yervoy] and nivolumab [Opdivo] vs sunitinib [Sutent], and this issue limited the number of patients in our pooled analysis. Another important limitation of this analysis is the lack of randomization. We tried to account for the impact of potential imbalances in baseline characteristics by adjusting for factors that are commonly thought to be involved in patient selection for nephrectomy, such as patient's age and performance status. However, there are likely other factors that were not adequately captured in these trials and could not be fully controlled for, and in the absence of a pre-specified randomization, the results of any analysis on the effect of cytoreductive nephrectomy on outcomes should only be considered exploratory and hypothesis generating. This means that our results only found an association between prior cytoreductive nephrectomy and better outcomes. However, outside a randomized trial, we cannot make any conclusion about the causal relationship between conducting cytoreductive nephrectomy and improved outcomes.

"Outside a randomized trial, we cannot make any conclusion about the causal relationship between conducting cytoreductive nephrectomy and improved outcomes," says Jaleh Fallah, MD.

Neal Shore, MD, FACS, and Brian Shuch, MD, provide closing thoughts on the potential of PET/CT imaging to improve patient care in kidney cancer.

Potential Impact of PET/CT Imaging on Improving Patient Care

UroView

Urologists review clinical trials investigating new imaging options in kidney cancer, including the ZIRCON study looking at girentuximab.

Overview of Clinical Trials for New Imaging Options for Kidney Cancer

Kidney cancer specialists discuss recent advances in imaging for diagnosis and disease management, highlighting sestamibi and zirconium scans.

Advances in Imaging for Kidney Cancer Diagnosis and Management

Brian Shuch, MD, and Neal Shore, MD, FACS, discuss the staging and treatment of kidney cancer, including when to biopsy and how often to do follow-up imaging.

Staging and Treatment Decisions for Kidney Cancer

Limitations of Conventional Imaging for Assessing Renal Masses

Experts on kidney cancer review challenges associated with limitations of conventional imaging for assessing renal masses and how to potentially improve sensitivity and specificity.

Kidney Cancer

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