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This announcement follows the successful launch of generic tiopronin delayed-release tablets last year.

Tiopronin delayed-release tablets available in US for patients with cystinuria

The study will evaluate the investigational drug product ONC175 (orellanine) in patients with metastatic clear cell or papillary renal cell carcinoma.

FDA greenlights trial of orellanine in metastatic renal cell carcinoma

“The study suggests that exercise would be an effective intervention for men with prostate cancer who express concern about sexual dysfunction, and that exercise medicine should be considered a key part of their treatment,” says Daniel Galvão, PhD. 

Exercise may improve erectile function in men with prostate cancer

The overall prevalence of kidney stones remained stable, with a notable increase observed among women. 

Kidney stone prevalence is increasing in women, study findings show

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In these videos, expert surgeons demonstrate robot-assisted penile inversion vaginoplasty, single-stage metoidioplasty, and simple orchiectomy for transgender patients.

Transgender surgery: Videos demonstrate cutting-edge techniques

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

A long-term, multicenter analysis of patients undergoing robot-assisted radical cystectomy for non-muscle invasive bladder cancer identified multiple predictors of upstaging.

®, study author Neeraja Tillu, MD, provided an overview of the study and its notable findings.

“Our multicenter, long-term study examined outcomes in patients diagnosed with non–muscle invasive bladder cancer who had undergone robot-assisted radical cystectomy with intracorporeal urinary diversion. We analyzed data from 355 patients treated between 2004 and 2022 across 3 high-volume institutions. The primary aim was to evaluate the predictors of disease upstaging at the time of surgery and its impact on long-term survival outcomes,” explained Tillu, a urologic oncology fellow at Icahn School of Medicine at Mount Sinai in New York, New York.

Tillu reported that in their cohort, 34.4% of patients experienced upstaging post surgery.

Neeraja Tillu, MD, on the study Long-term multicentre analysis of robot-assisted radical cystectomy for non-muscle-invasive bladder cancer

Neeraja Tillu, MD, discusses predictors of upstaging following RARC for NMIBC

“This group had notably worse overall survival and cancer-specific survival. Key predictors involved with worse overall survival were advanced age (more than 83 years), carcinoma in situ, with concomitant T1 or TA disease, variant histology, squamous cell carcinoma. Conversely, patients with higher BMI [body mass index] and those presenting exclusively with carcinoma in situ were less likely to be upstaged,” Tillu said.

In the interview, Tillu outlined the benefits of discerning predictors of upstaging.

“Identification of significant predictors has improved our pre-op counseling…This sort of transparency…guides in making choices regarding the timing of radical cystectomy,” Tillu said.

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. 

“Identification of significant predictors [of upstaging] has improved our pre-op counseling," says Neeraja Tillu, MD.

Yesterday, March 11, 2025, the US House of Representatives voted 217-213 to pass a Continuing Resolution (CR) bill that includes an approximately 57% cut to the Department of Defense’s (DOD’s) Congressionally Directed Medical Research Programs (CDMRP), which fund research projects in disease states such as prostate cancer, bladder cancer, kidney cancer, and interstitial cystitis.

Specifically, the bill cuts funding for CDMRP from $1.509 billion in FY2024 to $650 million in FY2025. Prostate and kidney cancer research is currently funded at $110 million and $50 million, respectively.

 It is unclear what the budget cut, if fully approved, would mean for these programs specifically.

The bill will now move to the Senate, where it needs bipartisan support before it reaches the desk of President Donald Trump for final approval.

 A government shutdown would ensueIf action is not reached on the CR by Saturday, March 15.

If passed, the Full-Year Continuing Appropriations and Extensions Act, 2025 would fund the government through September 30, which marks the end of the fiscal year.

Several urologic organizations have opposed the cut to medial research programs, including Zero Prostate Cancer, a nonprofit prostate cancer organization, who issued a statement on the House decision yesterday.

“ZERO will continue to call on the DOD to protect and prioritize [Prostate Cancer Research Program] funding—because lives depend on it,” they stated in a news release.

 “We will also continue to advocate for increased education and the importance of screening. Americans deserve a future where prostate cancer is detected early, every patient receives unwavering support, and lifesaving care is within reach for all. This has been our steadfast mission for nearly 30 years, and we will not stop now.”

The American Urological Association (AUA) has also urged its members to contact their representatives to advocate for CDMRP to be funded at the current levels for the remainder of FY2025.

 to send to legislators, the AUA noted that the kidney cancer CDMRP is the only dedicated source of funding for kidney cancer research. The organization also pointed out the importance of prostate cancer funding for active-duty service members, as 80% of this population is comprised of men.

The American Cancer Society also shared a release expressing the risk that this budget cut poses to vital cancer research, specifically in prostate cancer.

“A 57% reduction in CDMRP appropriation will most certainly risk vital advances in cancer research, halting much needed innovation. CDMRP is responsible for several clinical cancer advancements, especially for prostate cancer, the most diagnosed cancer and the second most common cause of cancer-related death for men in the United States,” said Lisa Lacasse, president of the ACS Cancer Action Network (CAN), in the release.

“Cancer patients and their families rely on Congress to maintain the critical role of government in the cancer fight, because robust funding is not just an investment in science but a commitment to patient’s lives. ACS CAN calls on Congress to reinvest in the fight against cancer by prioritizing investments in research and prevention that will end cancer as we know it, for everyone.”

Adam B. Weiner, MD, a urologic oncologist at Cedars-Sinai Medical Center in Los Angeles, California, shared his concerns about the proposed budget cuts in correspondence with 

“A key impact of the CDMRP is its emphasis on funding innovative, high-risk research that might otherwise be overlooked by traditional grant mechanisms like those of the National Institutes of Health (NIH). By supporting early-stage ideas, the program enables groundbreaking discoveries that can later attract larger investments from federal agencies and private industry. This approach has led to paradigm shifts in various medical fields, including precision medicine, immunotherapy, and stem cell research,” Weiner noted.

“The CDMRP also provides early career mentored grants specifically for physician scientists. This is absolutely critical to help academic urologists. Early career funding for surgeon scientists is one of the most important factors for success as we are often balancing building new surgical practices. By further limiting the pool of available funding for urologists, the number of future urology principal investigators will decline and research progress for our field will suffer.

The US leads the world in advancements in biomedical research, and our future as leaders in this field is unclear.”

The CR includes other implications for urologists as well. The bill also includes language that would extend telehealth flexibilities through the end of September. Without Congressional action, these provisions are set to expire on March 31, 2025.

In a news release from the American Telemedicine Association, Kyle Zebley, Executive Director of ATA Action, applauded this inclusion, stating, “We appreciate Congress taking action to prevent a lapse in these vital telehealth flexibilities. While we would have preferred a longer extension, this step ensures uninterrupted access to telehealth services for patients and clinicians, as we continue working toward permanent solutions that reflect the needs of modern healthcare.”

The Association is urging Congress to reinstate these flexibilities as soon as possible.

1. ZERO Prostate Cancer responds to devastating 57% cut to lifesaving medical research programs. News release. Zero Prostate Cancer. March 11, 2025. Accessed March 12, 2025. https://www.prnewswire.com/news-releases/zero-prostate-cancer-responds-to-devastating-57-cut-to-lifesaving-medical-research-programs-302399157.html

2. Action Center. American Urological Association. Accessed March 12, 2025. https://www.auanet.org/advocacy/action-center

3. House passes bill to fund federal agencies through September, though prospects unclear in Senate. Associated Press (AP). Accessed March 12, 2025. https://apnews.com/article/congress-budget-funding-government-shutdown-e027a644af4152377b8cf99f6a91102f

4. U.S. House misses critical opportunity to boost cancer research and prevention funding; Future progress in jeopardy. News release. American Cancer Society. March 11, 2025. Accessed March 12, 2025. https://www.fightcancer.org/releases/us-house-misses-critical-opportunity-boost-cancer-research-and-prevention-funding-future

5. ATA Action applauds inclusion of Medicare telehealth flexibilities in draft Continuing Resolution, urges Congress to reinstate provisions as soon as possible. American Telemedicine Association. March 8, 2025. Accessed March 12, 2025. https://www.americantelemed.org/press-releases/ata-action-applauds-inclusion-of-medicare-telehealth-flexibilities-in-draft-continuing-resolution-urges-congress-to-reinstate-provisions-as-soon-as-possible/

This bill would cut funds for research projects in disease states such as prostate cancer, bladder cancer, kidney cancer, and interstitial cystitis.

House passes bill that includes 57% budget cut to medical research programs

A 35-year-old male from Sudan was hospitalized with a right obstructing 1-cm ureteral stone seen on KUB. The KUB also revealed curvilinear calcification in the bladder wall. The patient was taken to the operating room for ureteroscopy and laser lithotripsy.

During cystoscopy, a rim of calcification was seen along the right ureteric ridge (figure 1a). A biopsy of this area was taken with the pathology shown in figure 1b.

B. Squamous cell carcinoma of the bladder

A 35-year-old male from Sudan presented with a 1-cm obstructing ureteral stone and curvilinear calcification in the bladder wall, as seen on KUB imaging. The patient underwent ureteroscopy and laser lithotripsy. During cystoscopy, calcification was observed along the right ureteric ridge. A biopsy was performed on this area to further investigate the pathology. The findings from the biopsy are crucial for understanding the underlying condition contributing to the calcification and obstruction, which may have implications for the patient's treatment and management.

A 35-year-old male from Sudan was hospitalized with a right obstructing 1-cm ureteral stone seen on KUB. The KUB also revealed curvilinear calcification in the bladder wall. The patient was taken to the operating room for ureteroscopy and laser lithotripsy. During cystoscopy, a rim of calcification was seen along the right ureteric ridge. What is the diagnosis?

Residents Corner

Quiz: Sandy patch on cystoscopy

The first patient has been enrolled in the phase 3 PROSTATE-IQ trial (NCT06274047), assessing the ability of the ArteraAI Prostate Test to accurately identify patients who can safely reduce or avoid treatment with hormone therapy, Artera announced in a news release.

The goal of the trial is to improve quality of life for patients with low-risk disease by enabling them to reduce or avoid the adverse effects associated with androgen deprivation therapy (ADT). The study will include patients who have biochemical recurrence following prostatectomy.

“We are excited to partner with some of the world’s leading institutions on this transformational clinical trial, one that can radically improve not only patient outcomes but the quality of life for men with prostate cancer,” said Tim Showalter, MD, chief medical officer of Artera, in a news release from the company.

 “There has been tremendous eagerness from the medical community to start adopting risk stratification tools in this fashion with this patient population—those with biochemical recurrence after prostatectomy. We’re excited to see our test being used to help determine the optimal treatment therapy, reduce unnecessary [adverse] effects, and increase confidence in treatment planning.”

In total, the PROSTATE-IQ trial plans to enroll 120 patients at up to 11 clinical trial sites across the US.

For the study, ArteraAI will be used to evaluate post-prostatectomy surgical specimens to stratify patients based on their risk. Patients deemed low risk will be randomly assigned to either 6 months of ADT or to apalutamide (Erleada) monotherapy. Those determined to be high risk will be randomly assigned to either 24 months of ADT or to 6 months of ADT with apalutamide.

The investigators will evaluate the ability to personalize treatment based on disease aggressiveness and determine whether apalutamide-based treatment can reduce fatigue and other adverse effects.

Patients are eligible for enrollment in the study if they have histologically confirmed prostate cancer, a prostate-specific antigen level of 0.1 ng/mL or higher following radical prostatectomy, an ECOG performance status of 2 or lower, and adequate organ function. Participants must also be older than 18 years and a candidate for salvage radiation and ADT treatment.

The primary outcome measure for the study is general quality of life, which according to Artera will be measured using questionnaires and wearable devices. This will include the Functional Assessment of Chronic Illness Therapy-Fatigue scale. The company also noted, “Secondary end points will include physician-reported toxicity, patient-reported activity, sleep, cognitive function, mental health, body composition changes, and cancer control metrics.”

Primary completion of the trial is expected for June 2027.

ArteraAI is a multimodal artificial intelligence biomarker test that uses patients’ digital biopsy images and clinical data to help predict which patients may benefit from a particular therapy. The prognostic test has been validated in patients who have undergone active surveillance, radiation therapy, or had a radical prostatectomy.

Across all National Comprehensive Cancer Network risk groups, the test can help to assess the risk of 10-year distant metastasis and prostate cancer-specific mortality. In lower-risk patients, the test can be used to evaluate the relative risk of adverse pathology at radical prostatectomy to help guide decisions surrounding active surveillance. In intermediate-risk patients, the test can help predict the benefit of adding short-term ADT to radiation therapy.

1. Artera announces 1st patient enrolled in PROSTATE-IQ trial to reduce burden of hormone therapy in men with prostate cancer recurrence after prostatectomy. News release. Artera. March 11, 2025. Accessed March 11, 2025. https://www.businesswire.com/news/home/20250311717751/en/Artera-Announces-1st-Patient-Enrolled-in-PROSTATE-IQ-Trial-to-Reduce-Burden-of-Hormone-Therapy-in-Men-with-Prostate-Cancer-Recurrence-After-Prostatectomy

2. PROSTATE-IQ: parallel randomized study of personalized apalutamide treatment and evaluation to improve quality of life in post-operative radiation with androgen axis suppression: a phase III multi-center study for men with detectable PSA after prostatectomy for prostate cancer. ClinicalTrials.gov. Updated November 12, 2024. Accessed March 11, 2025. https://clinicaltrials.gov/study/NCT06274047

3. Artera announces expansion of the ArteraAI Prostate Test to inform active surveillance decisions for lower risk prostate cancer patients. News release. Artera. August 6, 2024. Accessed March 11, 2025. https://www.businesswire.com/news/home/20240806340589/en/Artera-Announces-Expansion-of-the-ArteraAI-Prostate-Test-to-Inform-Active-Surveillance-Decisions-for-Lower-Risk-Prostate-Cancer-Patients

4. ArteraAI Prostate Test. Artera. Accessed March 11, 2025. https://artera.ai/for-clinicians

The goal of the trial is to improve quality of life by identifying patients who can safely reduce or avoid treatment with hormone therapy.

Miroslav L. Djordjevic, MD, PhD

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