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Winoker is the director of endourology and director of the Center for Kidney Stone Disease at Lenox Hill and an assistant professor of urology at The Zucker School of Medicine at Hofstra/Northwell in New York, New York.

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

Jared S. Winoker, MD, addresses the wide range of stone burdens treated by the CVAC system for the study.

Study results show CVAC 2.0 is safe, efficacious for wide range of kidney stones

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The application is seeking an expanded indication of talazoparib plus enzalutamide for mCRPC.  

FDA Advisory Committee unanimously votes against talazoparib plus enzalutamide for mCRPC

The committee voted 4-5 in opposition of a favorable benefit-risk profile.

FDA Advisory Committee finds evidence for UGN-102 inconclusive, cites uncertainty in benefit-risk

Results from the phase 3 AMPLIFY trial are intended to support an application to the FDA for potential approval of 64Cu-SAR-bisPSMA. 

Pivotal trial launches of 64Cu-SAR-bisPSMA in BCR of prostate cancer 

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Timothy S. Ayers is an associate at Winston & Strawn LLP, Washington, DC.

Even after the tremendous victory won by the American Lithotripsy Society and the Urology Society of America last year in federal court, urologists still must be concerned with Stark II and the federal anti-kickback statute.

Stark II in 2003: What urologists still need to know

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 markets have certainly been a roller coaster lately. After a solid start to the year, the US markets have been upended by the will-they-or-won’t-they Trump administration tariffs, sticky inflation, and interest rates unlikely to drop significantly anytime soon. This volatility is not unexpected when a stock market setting new record highs suddenly experiences significant headwinds. Economic indicators also show signs of an economic slowdown. Unemployment has been creeping up, and new hires have been trending down. However, overall, the US economy continues to look fairly strong. Despite this, the stock markets have been jumping up and down from one day to another.

For investors, it is critical not to overreact. You need to block out the surrounding noise and follow your investment strategy in the face of volatile markets. Actions based on emotion and fear can cause you to make mistakes that can harm your long-term investment performance. In 2020, I wrote an article during another period of high volatility (the COVID-19 shutdown) and provided some insights for investing in these environments.

• Fight the impulse to sell your holdings if the markets are dropping. Selling after drops can make temporary losses permanent and difficult to recover. Although it can be difficult emotionally, sticking to your investment strategy may be healthier for your portfolio. It is important to continue monitoring your investments, but remember the long-term reasons the investment is in your portfolio. What role is it playing? If it is still a good fit, holding the investment may be the better long-term strategy.

• Remember that you are investing for the long term. Markets have always fluctuated up and down, and during your lifetime, you are likely to experience several significant declines. Investors should ignore the noise and stay disciplined in their designed investment strategy, which was created specifically to avoid these pitfalls.

• Review your risk tolerance. Risk you took on years ago may no longer make sense given your current circumstances and stage of life.

• Make sure your portfolio is well diversified. Volatile markets have a way of exposing improperly diversified portfolios.

• Rebalance your portfolio. Market volatility can skew your allocation from its original target. Certain assets will be more affected by market swings and will move outside their target allocations. Rebalance your portfolio by selling positions that have become overweight in relation to the rest of your portfolio and move the proceeds to positions that have become underweight.

• If you must trade during volatile markets, there are defensive steps you can take to protect your positions. Stop orders and stop-limit orders can help shield unrealized gains or limit potential losses on an existing position.

• Consider adding defensive assets such as cash and cash equivalents, Treasury securities, and other US government bonds. These can help stabilize a portfolio when stocks are slipping.

Additionally, if you are fortunate to have excess resources, there may be opportunities to take advantage of the down market. However, it is best to proceed with caution. If you determine you can invest in a volatile environment, the best approach is to do so over a period of time. It is impossible to tell when the markets have hit their bottom. Do not try to guess and invest everything in 1 lump sum. If markets continue to decline, you could lose a significant amount. It is better to break the investment into smaller increments. If you are wrong, you are not wrong with all the money you planned to invest. This strategy is called dollar-cost averaging (DCA). With a DCA strategy, it is best to select 1 day per week or 1 day per month to invest a smaller percentage of the total amount you plan to invest. Selecting a day and sticking to it will enable you to ignore the outside noise. If markets continue to decline, you are incrementally buying on the downslope and will be in a better position when markets recover.

1. Witz J. COVID-19 and market fluctuation: what you should do. 

 March 24, 2020. Accessed March 20, 2025. https://www.urologytimes.com/view/covid-19-and-market-fluctuation-what-you-should-do

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"If you determine you can invest in a volatile environment, the best approach is to do so over a period of time," writes Jeff Witz, CFP.

Money Matters: How to cope with market volatility in 2025

Patients who underwent nerve -sparing during robot-assisted radical prostatectomy (RARP) guided by the NeuroSAFE technique demonstrated improved erectile function at 1 year compared with patients who underwent standard RARP, according to findings from the phase 3 NeuroSAFE PROOF trial (NCT03317990).

The NeuroSAFE technique also led to improvements in urinary continence at 3 months, but this benefit was not sustained.

The data were presented at the 40th Annual European Association of Urology Congress in Madrid, Spain and published in 

“When we perform robotic radical prostatectomy, we perform a balancing act, balancing the opportunity to remove the cancer and cure it with the potential [adverse events] that come from removing important functional tissue that's closely approximated to the prostate,” explained presenting author Greg Shaw, BSc, MBBS, MD, FRCS(Urol), of the University College of London, United Kingdom. “We tend to err on the side of oncological control. Many patients who have organ-confined disease on the definitive pathology have non-nerve sparing surgery; we don't spare nerves when we could have. The NeuroSAFE procedure is an intraoperative frozen section technique. The surgeon gets feedback in real time during the operation. Having performed a nerve spare, they get to find out if that's resulted in a significant positive surgical margin, which may represent an issue with oncological control. It gives them an opportunity to regain that oncological control by performing a secondary resection.”

In total, the investigators enrolled 407 patients across 5 centers in the UK. Participants were randomly assigned 1:1 to receive NeuroSAFE RARP (n = 204) or standard RARP (n = 203). Following the procedure, 190 and 191 patients comprised the modified intent-to-treat population in each arm, respectively.

Data showed a longer operative time with the NeuroSAFE procedure vs with standard RARP. Specifically, the average surgical time was 174.4 minutes in the NeuroSAFE arm vs 131.4 minutes in the standard arm.

However, Shaw noted during the presentation, “That investment of time translated to an increase in the amount of nerve sparing that we were able to perform.”

Overall, 82.1% of patients in the NeuroSAFE arm were able to receive bilateral nerve-sparing compared with 56.4% of patients in the standard arm.

Patients in the NeuroSAFE arm also reported better erectile function at 12 months based on International Index of Erectile Function (IIEF-5) scores. Specifically, the average IIEF-5 score was 12.7 among patients in the NeuroSAFE arm vs 9.7 in the standard RARP arm (adjusted mean difference, 3.18; 95% CI, 1.62 to 4.75; 

Put another way, at 12 months following surgery, 38.7% of patients in the NeuroSAFE arm reported no or mild erectile function, compared with 22.8% of patients in the standard arm. Conversely, severe erectile function was reported in 38% of patients in the NeuroSAFE arm vs 56% of patients in the standard arm.

Measures of urinary continence at 3 months also favored the NeuroSAFE arm. The average ICIQ score was 5.8 in the NeuroSAFE arm vs 7.4 in the standard arm (adjusted mean difference, -1.41; 95% CI, -2.42 to -0.41; 

 = .006). However, this benefit was not sustained at 6 months, with an average score of 4.5 in the NeuroSAFE arm vs 5.1 in the standard RARP arm (adjusted mean difference, -0.37; 95% CI, -1.35 to 0.62; 

Oncological outcomes were similar between the 2 arms at 12 months. However, Shaw cautioned during the presentation, “We acknowledge that 12 months is a very early end point for oncological outcomes in prostate cancer. We will report on subsequent time points as our data matures.”

Specifically, prostate-specific antigen (PSA) persistence was observed in 3.8% of patients in the NeuroSAFE arm and 2.7% of patients in the standard arm. Similarly, biochemical recurrence was reported in 5.5% and 3.7% of patients, respectively.

However, the receipt of adjuvant treatment was shown to be higher in the NeuroSAFE arm (4.4% vs 1.1%). Shaw noted, “It's worth bearing in mind that this is treatment that is administered on the perception of adversity based on a pathological report. This is not driven by PSA. It's also no longer recommended practice.”

The investigators then conducted a pre-defined subgroup analysis to assess outcomes among those who would not typically have received bilateral nerve-spare. Among these patients, the average erectile function score per IIEF-5 was 12.6 in the NeuroSAFE arm (n = 120) compared with 8.7 in the standard arm (n = 114) at 12 months following surgery (mean difference, 4.4; 95% CI, 2.63 to 6.26; 

 < .001). There was no significant difference between the 2 groups in urinary continence scores at 3 months.

“Our results show that by using NeuroSAFE, nearly twice as many men don’t have to face potentially life-changing loss of erectile function after prostate surgery,” concluded Shaw in a news release on the findings.

 “It is an involved procedure that requires expertise, but it isn’t expensive, particularly given the benefits it offers for patients, and most importantly doesn’t jeopardize cancer control. NeuroSAFE wouldn’t be appropriate for all patients, as many can safely have nerve-sparing surgery using standard robotic techniques. But for younger patients and those who wouldn’t normally be seen as eligible for nerve-sparing surgery, it offers them a greater chance to hold onto their quality of life.”

1. Almeida-Magana R, Dinneen E, Al-Hammouri T, et al. NeuroSAFE versus standard robot-assisted radical prostatectomy (NeuroSAFE PROOF): a randomised, controlled, patient-blinded, IDEAL stage 3 trial. Presented at: 40

 Annual European Association of Urology Congress. Madrid, Spain. March 21-24, 2025. Abstract GC9

2. Dinneen E, Almeida-Magana R, Al-Hammouri T, et al. Effect of NeuroSAFE-guided RARP versus standard RARP on erectile function and urinary continence in patients with localised prostate cancer (NeuroSAFE PROOF): a multicentre, patient-blinded, randomised, controlled phase 3 trial. 

. 2025. https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(25)00091-9/fulltext

3. Twice as many men recover erectile function after improved prostate cancer surgery. News release. European Association of Urology. March 24, 2025. Accessed March 27, 2025. https://www.eurekalert.org/news-releases/1077548

The NeuroSAFE technique, used during robot-assisted radical prostatectomy (RARP), enhances erectile function at one year post-surgery compared to standard RARP, as shown in the NeuroSAFE PROOF trial. While it also initially improves urinary continence at three months, this benefit diminishes by six months. The technique involves intraoperative frozen section analysis, allowing real-time feedback and potential secondary resection to maintain oncological control. Although operative time is longer, the technique increases nerve-sparing rates without compromising cancer control, offering significant quality-of-life benefits for certain patient groups.

“Our results show that by using NeuroSAFE, nearly twice as many men don’t have to face potentially life-changing loss of erectile function after prostate surgery,” says Professor Greg L. Shaw. 

NeuroSAFE procedure for RARP leads to improved erectile function

A subanalysis from the European Randomized study of Screening for Prostate Cancer (ERSPC) showed that participants who failed to attend a prostate cancer screening session despite being invited faced an increased risk of prostate cancer-specific mortality (PCSM).

Conversely, those who did attend a screening session demonstrated a 23% reduced risk of PCSM. The data were presented at the 40

 Annual European Association of Urology Congress in Madrid, Spain.

“Our study identifies that men who were invited for screening, but do not attend screening appointments are at significantly higher risk of dying from prostate cancer compared to men who were not offered screening or accepted an invitation for screening,” explained lead author, Renée Leenen MD, a PhD researcher at the Erasmus MC Cancer Institute, in a news release on the findings.

 “We need to better understand who these men are, why they choose not to attend appointments, and how to motivate them. This will help us to design population-based prostate cancer screening programs that encourage higher rates of informed participation. Tackling attendance rates in this way could be a big factor in the long-term success of a national prostate screening program.”

Overall, the ERSPC included men aged 55 to 69 years who were randomly assigned to the screening arm (n = 72,460) or to the control arm (n = 88,920). Participants were recruited across Finland, the Netherlands, Italy, Sweden, Switzerland, Belgium, and Spain. Follow-up was conducted over 20 years.

Participants in the screening arm who did not attend any of the screening rounds offered were considered non-attenders. In total, 12,401 (17%) participants in the study were non-attenders.

Data showed a rate ratio (RR) of 1.39 (95%CI 1.18-1.63) when comparing non-attenders vs the control arm and 0.77 (95%CI 0.69-0.85) when comparing attenders with the control arm. In other words, compared to the control group, non-attenders demonstrated a 39% increased risk of PCSM, while attenders demonstrated a 23% lower risk.

The authors noted, “Sensitivity analysis showed no stat. sig. differences between pre- or post-randomization consent (sHR, 0.71; 95% CI, 0.46-1.29).”

When comparing the attenders vs the non-attenders, those who attended a screening session demonstrated a 45% (RR, 0.55; 95% CI, 0.47-0.65) decreased odds of PCSM.

According to Tobias Nordström, MD, PhD, of the Karolinska Institute in Sweden, these data suggest that the benefit of screening may be greater than previously assumed.

“For countries around Europe that are planning to introduce a national prostate screening program, this analysis focusing on attendance shows that men who participate in screening have a much-improved long-term benefit than what we’ve seen from previous studies,” he said in the news release.

However, in the non-responders arm, these findings may point to a group of men who need extra attention. According to Leenen, the choice to not participate in screening may reflect overall behaviors of care avoidance, which may explain why non-attenders demonstrated a higher risk of PCSM vs the control arm.

“It may be that men who opted not to attend a screening appointment are care avoiders, meaning they’re less likely to engage in healthy behaviors and preventative care in general. This is the opposite behavior of people who are perhaps more health conscious and are more likely to attend a screening appointment.”

The authors warn that non-attendance may be the greatest barrier to successful implementation of a population-based screening program. Thus, these data “emphasize the urgent need to address awareness, informed participation and inequalities in access,” the authors write.

“But it highlights a group of men who need our attention, as they’re more at risk of developing advanced prostate cancer and dying from it,” Nordström added. “We need to better understand why these men might actively choose not to participate in screening, despite being invited to attend, and how this behavior is linked to worse outcomes when they get a diagnosis.”

Full results from the ERSPC subanalysis are expected to be published later this year.

1. Leenen RCA, Mulder E, Remmers S, et al. Prostate cancer mortality in men not attending a population-based screening program: The good, the bad, and the ugly after 20-year follow-up in the European Randomized study of Screening for Prostate Cancer. Presented at the 40

 Annual European Association of Urology Congress. Madrid, Spain. March 21-24, 2025. Abstract A0279

2. Worse outcomes for men who avoid prostate cancer screening. News release. European Association of Urology. March 20, 2025. Accessed March 21, 2025. https://www.eurekalert.org/news-releases/1077327

A subanalysis from the ERSPC revealed that men who skipped prostate cancer screening despite being invited had a higher risk of prostate cancer-specific mortality (PCSM). Attendees of the screening showed a 23% reduced risk of PCSM. The study highlighted the need to understand and motivate non-attenders, as their behavior may reflect broader care avoidance tendencies. The findings suggest that non-attendance is a significant barrier to effective population-based screening programs, emphasizing the importance of addressing awareness, informed participation, and access inequalities to improve screening outcomes.

“Our study identifies that men who were invited for screening, but do not attend screening appointments are at significantly higher risk of dying from prostate cancer compared to men who were not offered screening or accepted an invitation for screening,” says Renée Leenen MD.

Avoidance of prostate cancer screening linked to increased risk of PCSM

Updated data from the phase 3 BOND-003 trial (NCT04452591) continue to support the efficacy, safety, and tolerability of cretostimogene grenadenorepvec in patients with high-risk BCG-unresponsive non–muscle invasive bladder cancer (NMIBC).

The data were presented by Trinity J. Bivalacqua, MD, PhD, at the 40th Annual European Association of Urology Congress in Madrid, Spain.

Overall, updated efficacy data showed a complete response (CR) rate at any time point of 75.5% (95% CI, 66.3-83.2%). The 12-month landmark CR rate was 46% (95% CI, 36.9-56.1). There are also 30 confirmed CRs that have reached the 24-month time point. Per Kaplan-Meier estimate, the 12- and 24-month CR rates are 50% (95% CI, 39.6-58.9%) and 41% (95% CI, 30.4-50.8%), respectively. The CR rate was consistent across patient subgroups.

Additionally, at 12 months, 97.3% of patients were free from progression to muscle-invasive bladder cancer, and the cystectomy-free survival was 90.0%.

Data also showed a sustained duration of response (DOR) in these patients. The estimated DOR was 63.7% (95% CI, 51.8-73.3%) at 12 months and 58.7% (95% CI, 46.4-69.0%) at 24 months. The median DOR has not been reached but exceeds 28 months (95% CI, 14.3-NE). The median follow-up is 22.3 months.

Bivalacqua noted during the presentation, “What this demonstrates very clearly is that patients that have a durable response at 12 months continue with a durable response at [24] months. We can hypothesize that this may relate to the innate to adaptive switching with immunogenic memory. However, this has never been proven.”

Cretostimogene was also generally well-tolerated, with the majority of adverse events (AEs) being grade 1 or 2. In total, 64.3% of patients experienced any grade treatment-related AE (TRAE). The most common TRAEs (reported in more than 10% of patients) included bladder spasms (25%), pollakiuria (20.5%), urgency (19.6%), dysuria (15.2%), and hematuria (13.4%). The median time to TRAE resolution was 1 day. There were no grade 3 or higher TRAEs, treatment-related discontinuations, or deaths.

Bivalacqua then outlined translational data on cretostimogene. Data collected in the induction period showed that levels of creto titer and GM-CSF in the urine both peaked following instillation and were sustained locally for 4 to 5 days. According to Bivalacqua, these data suggest that there is effective payload delivery.

In the maintenance phase, Bivalacqua noted, “We see similar pharmacokinetics with a peak and trough pattern as previously showed. And the titers are present throughout the maintenance period.”

Cretostimogene also demonstrates stable and robust antibody and anti-tumor response. Antibody response was shown to be associated with clinical outcomes.

There were no creto levels detected systemically, with concentration remaining in the bladder even with repeat dosing. Based on these findings, the investigators concluded that post-cretostimogene close contact precautions are not needed.

Updated data from the phase 3 BOND-003 trial underscore the efficacy, safety, and tolerability of cretostimogene grenadenorepvec in high-risk BCG-unresponsive NMIBC patients. The trial demonstrated a complete response rate of 75.5% at any time point, with a 12-month CR rate of 46% and a 24-month CR rate of 41%. The treatment was well-tolerated, with most adverse events being mild. Translational data indicated effective payload delivery and robust antibody responses. Cretostimogene has received FDA breakthrough therapy and fast track designations, highlighting its potential as a significant advancement in bladder cancer treatment.

"Now with the new translational data indicating that post-treatment close contact precautions are unnecessary, I am confident that cretostimogene will represent a breakthrough in bladder cancer treatment, if approved by the FDA," says Trinity J. Bivalacqua, MD, PhD. 

Timothy S. Ayers

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