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

The Continuity Grant will support projects in bladder cancer and/or upper tract urothelial carcinoma that were previously scientifically reviewed, approved, and funded.

BCAN launches $1 million grant for bladder cancer research impacted by federal funding cuts

Alpha1H was granted a fast track designation in November 2023.

Meeting with FDA paves way for phase 3 trial of Alpha1H in NMIBC

The level II code A9616 will be effective starting on October 1, 2025. 

CMS issues reimbursement code for PSMA-PET imaging agent Gozellix

Mulhall offers an unfiltered, evidence-based deep dive into testosterone evaluation and treatment nuances.

Pearls & Perspectives: Testosterone and the Future of Men’s Health, with John P. Mulhall, MD

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“It encompasses and contains the miTNM, PROMISE, PRIMARY, RECIP, PSMA-RADS, and E-PSMA concept and criteria all together,” says Jeremie Calais, MD, PhD.

Jeremie Calais, MD, on development of a prostate cancer imaging reporting template

"But as you get out of expert centers and academic sites that did it for years under research protocols, the level of the quality of the reads decreases," says Jeremie Calais, MD, PhD. 

Jeremie Calais, MD, on rationale for reporting template for PSMA-PET scans

The FDA has accepted a new drug application (NDA) for zoliflodacin, an investigational first-in-class, single-dose, spiropyrimidinetrione oral antibiotic for the treatment of adult and pediatric patients 12 years and older with uncomplicated gonorrhea, Innoviva Specialty Therapeutics announced in a news release.

The Prescription Drug User Fee Act (PDUFA) target action date for the application is December 15, 2025.

Zoliflodacin is an oral antibiotic that inhibits type II topoisomerase, a bacterial enzyme that plays a key role in bacterial function and reproduction. According to the company, “If approved, zoliflodacin would be the first new antibiotic for treating gonorrhea in decades.”

The FDA has also granted a Qualified Infectious Disease Product designation to zoliflodacin, which enables the agent to benefit from priority review and market exclusivity.

“Today’s acceptance of the zoliflodacin NDA marks significant progress toward delivering health care providers with a potential new oral treatment option for uncomplicated gonorrhea, including infections caused by drug-resistant strains,” said David Altarac, MD, Chief Medical Officer of Innoviva Specialty Therapeutics, in the news release.

 “We look forward to working closely with the FDA during its review and, if approved, we are committed to expediting the availability of zoliflodacin to patients in the U.S.”

The NDA for zoliflodacin is supported by data from several clinical trials conducted through a collaboration with the Global Antibiotic Research & Development Partnership (GARDP). This portfolio of studies includes a pivotal phase 3 trial (NCT03959527) that evaluated zoliflodacin vs a standard of care (SOC) regimen (500 mg ceftriaxone intramuscular plus 1g oral azithromycin) in patients with uncomplicated gonorrhea.

Overall, the trial met its primary end point by demonstrating that zoliflodacin was non-inferior to the SOC regimen regarding microbiological response at the urogenital site at the test of cure visit (6 +/- 2 days following treatment). Specifically, the microbiological cure rate was 90.9% in the zoliflodacin arm vs 96.2% in the ceftriaxone/azithromycin arm, representing a difference of 5.3% (95% CI, 1.4% to 8.7%) across patients in the micro-intent-to-treat (ITT) population.

The 2 cohorts also demonstrated comparable results on the trial’s secondary end point of microbiological response at extragenital (rectal or pharyngeal) sites. Specifically, at pharyngeal sites, the cure rate was 79.2% in the zoliflodacin arm vs 78.6% in the ceftriaxone/azithromycin arm (difference, -0.67%; 95% CI, -20.8 to 16.3). At rectal sites, the cure rate was 87.3% and 88.6%, respectively (difference, 1.23%; 95% CI, -14.4 to 12.6).

Zoliflodacin was generally well-tolerated in the trial. Treatment-emergent adverse events (TEAEs) occurred in 46.2% of patients in the zoliflodacin arm vs 46.4% of patients in the ceftriaxone/azithromycin arm. The most common TEAEs in the zoliflodacin arm included headache (9.9%), neutropenia (6.8%), and leukopenia (3.9%).

There were no deaths or serious adverse events reported in either arm.

In total, the phase 3 trial included 930 patients with uncomplicated gonorrhea, including patients living with HIV. The study enrolled participants across 16 clinical trial sites in the US, Belgium, the Netherlands, South Africa, and Thailand.

According to Innoviva, the phase 3 study was “the largest clinical trial ever conducted for a new treatment against gonorrhea infection.”

Those enrolled in the study were randomly assigned 2:1 to receive 3 g single-dose, oral zoliflodacin (n = 621) or to 500 mg ceftriaxone intramuscular plus 1g oral azithromycin (n = 309). The primary end point was microbiological cure by culture at urogenital sites in the micro-ITT populations, with a non-inferiority margin of 12%. The trial’s secondary end point was microbiological cure at extragenital sites.

“This important milestone demonstrates the crucial role that public-private partnerships can play in tackling the escalating global antimicrobial resistance crisis,” said Manica Balasegaram, Executive Director of GARDP, in the news release.

 “If zoliflodacin is approved, this collaboration paves the way for millions of people across the world to get access to a potentially powerful new drug to treat multidrug-resistant gonorrhea.”

1. Innoviva Specialty Therapeutics receives FDA New Drug Application acceptance for zoliflodacin, a first-in-class oral antibiotic for uncomplicated gonorrhea in adults. News release. Innoviva Specialty Therapeutics. Published online and accessed June 10, 2025. https://innovivaspecialtytherapeutics.com/innoviva-specialty-therapeutics-receives-fda-new-drug-application-acceptance-for-zoliflodacin-a-first-in-class-oral-antibiotic-for-uncomplicated-gonorrhea-in-adults/

2. FDA Grants Priority Review for Zoliflodacin New Drug Application for the Treatment of Uncomplicated Gonorrhea and Assigns Target PDUFA Date of December 15, 2025. News release. Innovia Specialty Therapeutics, Inc. Published online and accessed June 12, 2025. https://www.businesswire.com/news/home/20250612432209/en/FDA-Grants-Priority-Review-for-Zoliflodacin-New-Drug-Application-for-the-Treatment-of-Uncomplicated-Gonorrhea-and-Assigns-Target-PDUFA-Date-of-December-15-2025 

3. Luckey A, Broadhurst H, Daram P, et al. Oral zoliflodacin is non-inferior to a combination of ceftriaxone and azithromycin for treatment of uncomplicated urogenital gonorrhoea: results of a large global Phase 3 randomised controlled trial. Presented at: European Society of Clinical Microbiology and Infectious Disease Global Congress. April 27-30, 2024. Barcelona, Spain. https://gardp.org/wp-content/uploads/2024/04/Zoli001-Topline-ECCMID2024_final_V1.0_23Apr2024_.pdf

The FDA has accepted the NDA for zoliflodacin, a novel oral antibiotic for treating uncomplicated gonorrhea in patients aged 12 and older. Zoliflodacin, which inhibits type II topoisomerase, has been granted a Qualified Infectious Disease Product designation, allowing for priority review. Clinical trials, including a pivotal phase 3 study, demonstrated that zoliflodacin is non-inferior to the standard regimen of ceftriaxone and azithromycin. The trials showed comparable microbiological cure rates at urogenital and extragenital sites, with zoliflodacin being generally well-tolerated and no serious adverse events reported.

The NDA is supported by a pivotal phase 3 trial of zoliflodacin vs ceftriaxone plus azithromycin in patients with uncomplicated gonorrhea. 

News

FDA accepts new drug application for zoliflodacin for uncomplicated gonorrhea

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

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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. 

FDA accepts BLA for subcutaneous nivolumab in solid tumors

 suggest that the use of combination therapy in veterans with de novo metastatic-hormone sensitive prostate cancer (mHSPC) has increased over time and is associated with significantly longer overall survival (OS) vs androgen-deprivation therapy (ADT) monotherapy.

"Frequently new drugs work [well] in clinical trials and have little effect in the real world. In most clinical trials patients are younger (age 65-70) and predominantly White (<4% Black men) who can travel to high-end academic medical centers and are more physically fit," explained lead author Martin W. Schoen, MD, MPH, of Saint Louis University and St. Louis Veterans Affairs Medical Center, in correspondence with 

. "Our data comes from the entire VA, which includes ~25% Black men and men who are age 70-75 with heart disease, diabetes, etc. We show that in a real world population, the new therapies are effective. This study shows that the benefits of therapies in clinical trials is translating to benefits in the real world in a large group of patients."

In total, the retrospective cross-sectional study assessed 6216 veterans who received a diagnosis of de novo mHSPC from January 2013 to December 2022. The mean age of patients was 73.9 years (SD, 9.7). Among the 6216 patients included in the analysis, 3839 (61.8%) received ADT monotherapy, 1719 (27.7%) received an ARPI combination, and 658 (10.6%) received a docetaxel combination.

Overall, data showed an increase in the use of combination therapy over time, with combination treatment with either an ARPI or docetaxel becoming the majority of treatment in 2020. In 2020, combination therapy was used in 54% of patients (344 of 637), which rose to 63.1% of patients (465 of 737) in 2022.

Combination therapy was also associated with a significantly longer OS vs ADT monotherapy. Specifically, the mean OS was 40.3 months with combination therapy compared with 33 months with ADT monotherapy (HR, 0.80; 95% CI, 0.74 to 0.87).

There was no difference in OS between ARPI-based and docetaxel-based combination regimens. The mean OS was 40.4 months with ARPI combination therapy vs 40.2 months with docetaxel combination therapy (HR, 1.06; 95% CI, 0.92 to 1.22).

The study also assessed outcomes among 1540 patients who received combination therapy and had imaging reports for volume of disease. Those with high-volume disease demonstrated a significantly shorter survival; the mean OS was 33.3 months among those with high-volume disease compared with 62.5 months among those with low-volume disease (HR, 0.51; 95% CI, 0.43 to 0.60; 

Patients with high-volume disease were also more likely to receive combination therapy with docetaxel. Overall, 33.8% of patients with high-volume disease received docetaxel combination therapy vs 22.1% of patients with low-volume disease (

In patients with high-volume disease, data showed no difference in OS between those who received an ARPI combination vs those who received a docetaxel combination. Specifically, OS was 32.2 months among those who received an ARPI combination vs 34.7 months among those who received a docetaxel combination (HR, 1.06; 95% CI, 0.91 to 1.23).

However, in those with high-volume disease, combination therapy with an ARPI was associated with a longer progression-free survival (PFS) vs combination therapy with docetaxel. The mean PFS was 18.7 months with an ARPI combination vs 16.0 months with a docetaxel combination (HR, 0.80; 95% CI, 0.70 to 0.91).

Trends were similar in patients with low-volume disease. Data showed no difference in OS between those who received an ARPI vs docetaxel regimen (68.4 months vs 55.3 months; HR, 0.81; 95% CI, 0.58 to 1.13), but PFS was significantly longer among those who received an ARPI regimen. Specifically, the mean PFS was 39.7 months in those who received an ARPI combination vs 24.0 months in those who received a docetaxel regimen (HR, 0.57; 95% CI, 0.43 to 0.76).

"This research shows that these drugs have a dramatic effect on average patients in the VA, a group that is hard to treat," Schoen added. "This is the first large study that I am aware of that has compared chemotherapy vs hormonal therapies in matched patients in routine clinical practice."

The authors also concluded, “The data presented here suggest that an ARPI doublet combination treatment that avoids chemotherapy is a standard of care, and there is little evidence of benefit associated with a docetaxel doublet compared with an ARPI doublet."

“Future research into the role of docetaxel in triple combination is needed to elucidate the benefit of chemotherapy in mHSPC," they added.

1. Schoen MW, Doherty J, Eaton D, et al. Treatment patterns and survival among veterans with de novo metastatic hormone-sensitive prostate cancer. 

. 2025;8(5):e259433. doi:10.1001/jamanetworkopen.2025.9433

2. Treatment patterns, survival among veterans with de novo metastatic hormone-sensitive prostate cancer. News release. Saint Louis University. May 7, 2025. Accessed May 27, 2025. https://www.newswise.com/articles/treatment-patterns-survival-among-veterans-with-de-novo-metastatic-hormone-sensitive-prostate-cancer

Combination therapy for veterans with de novo metastatic hormone-sensitive prostate cancer (mHSPC) has increased over time, leading to significantly longer overall survival (OS) compared to androgen-deprivation therapy (ADT) monotherapy. The study analyzed 6216 veterans, revealing that combination therapy became predominant by 2020. No OS difference was found between androgen receptor pathway inhibitors (ARPI) and docetaxel combinations, but ARPI showed longer progression-free survival (PFS). High-volume disease patients had shorter OS, with docetaxel more frequently used. Future research is needed to explore docetaxel's role in triple combination therapies.

However, the data did not show any benefit of a docetaxel doublet vs an ARPI doublet.

Combination therapy linked to longer OS vs ADT in veterans with mHSPC

Sequential intravesical valrubicin and docetaxel (val/doce) demonstrated safety and efficacy as salvage therapy for patients with recurrent high-risk non–muscle invasive bladder cancer (NMIBC), according to data from a retrospective study published in 

“We found that sequential intravesical valrubicin and docetaxel (or Val/Doce) was safe, well-tolerated, and provided meaningful bladder-preservation outcomes for a particularly high-risk population, the majority failing at least 2 prior therapies,” said lead author Ian M. McElree, MD, in correspondence with 

®. “This study adds to the growing body of evidence supporting combination intravesical chemotherapy as a feasible option even after prior treatment failure. Nearly half of patients remained disease-free at 2 years, which is remarkable in this setting.”

For the study, the investigators retrospectively identified 139 patients with recurrent high-risk NMIBC who received treatment with val/doce between 2013 and 2024 at the University of Iowa. The median age of patients was 75 years (IQR, 69 to 81). Participants had a median of 2 prior lines of therapy; prior ttreatment included BCG in 66% of patients and gemcitabine/docetaxel in 96% of patients.

The primary end point was high-grade recurrence-free survival (HG-RFS).

At a median follow-up of 25 months (IQR, 10 to 51), 70 patients experienced a HG recurrence. Thus, the estimated HG-RFS rates were 58% at 1 year, 45% at 2 years, and 41% at 3 years. No factors were found to be associated with an increased risk of recurrence, including prior BCG (

 = .81), pretreatment carcinoma in situ (

 = .46), nor urothelial carcinoma present in the prostatic urethra/ducts (PUC; 

Further, 22 patients experience disease progression. The estimated progression-free survival rates were 95% at 1 year, 84% at 3 years, and 70% at 5 years. PUC prior to val/doce induction, which was present in 27 patients, was found to be associated with an increased risk of progression (

 = .02). No other factors were significantly associated with disease progression.

At 5 years, the estimated overall survival and cancer-specific survival rates were 68% and 91%, respectively.

In total, 73 patients (53%) experienced an adverse event (AE) during treatment. This translated to 94 AEs, which included 45 that were grade 1, 48 that were grade 2, and 1 that was grade 3. According to the authors, “The grade 3 AE was sepsis secondary to urinary tract infection requiring hospitalization and intravenous antibiotics.”

Overall, the most common AEs included bladder spasms (22%), urinary tract infection (9%), and hematuria (9%). AEs led to treatment discontinuation in 2 patients.

“As the treatment landscape becomes increasingly crowded with expensive agents, there’s real value in exploring intravesical approaches that are safe and readily available,” concluded McElree, who is an incoming resident at Vanderbilt University Medical Center in Nashville, Tennessee, and recent medical school graduate from the University of Iowa. “Moving forward, we’re focused on optimizing treatment sequencing—understanding when and how to use regimens like val/doce most effectively, and how to better match patients to salvage options based on tumor and patient-specific biomarkers.”

He added, “At the University of Iowa, we offer a range of bladder-sparing treatments through what we call the ‘Iowa Bladder-Sparing Algorithm’. This structured pathway includes options like val/doce and others, and we look forward to sharing outcomes from this broader cohort soon.”

1. McElree IM, Steinberg RL, Hougen HY, et al. Extended Outcomes of Intravesical Valrubicin and Docetaxel as a Secondary Salvage Treatment for Recalcitrant High-risk Non-muscle-invasive Bladder Cancer. 

. 2025:S2405-4569(25)00152-X. doi:10.1016/j.euf.2025.05.022

Sequential intravesical valrubicin and docetaxel (val/doce) has shown promise as a salvage therapy for recurrent high-risk non–muscle invasive bladder cancer (NMIBC), demonstrating safety and efficacy. In a retrospective study, nearly half of the patients remained disease-free at two years, with high-grade recurrence-free survival rates of 58% at one year and 45% at two years. The treatment was well-tolerated, with adverse events leading to discontinuation in only two patients. The study emphasizes the potential of combination intravesical chemotherapy, even after prior treatment failures.

“This study adds to the growing body of evidence supporting combination intravesical chemotherapy as a feasible option even after prior treatment failure," says Ian M. McElree, MD. 

Data support combination intravesical chemotherapy for high-risk NMIBC

Use of botulinum toxin (IncoA, Xeomin) with an anti-nausea patch appears to mitigate salivary gland toxicity in patients with metastatic prostate cancer who are undergoing prostate-specific membrane antigen (PSMA)-directed radiopharmaceutical therapy.

Investigators reported at the Society of Nuclear Medicine and Molecular Imaging 2025 Annual Meeting that this approach was associated with a 30% decrease in PSMA uptake by the salivary glands without compromising the treatment’s efficacy.

“In order for patients to maintain a good quality of life and continue with their treatments, it’s essential to address these serious dry mouth issues. Our study explored the use of Botox paired with a nausea patch on reducing radiation uptake to the salivary glands,” said Tianzhi Zhao, research assistant at the Theranostics Centre of Excellence in the Yong Loo Lin School of Medicine at the National University of Singapore, in a news release about the results.

“While TANDEM therapy strategies with combined 

Lu-PSMA-targeted RLT in a single low-activity cycle address certain challenges, effective salivary gland protection remains critical,” the authors wrote in their abstract.

The study evaluated data from 14 patients, with a mean age of 68.0 ± 8.1 years. Patients received percutaneous injections of 250 units of IncoA prior to their scheduled PSMA radioligand treatments. These were injected in 1 parotid gland as well as the contralateral submandibular glands 3-4 weeks for before 

Ac-radioligand therapy. Patients also received transdermal scopolamine patches behind the ears starting 72 hours before radioligand therapy and remaining until 2 hours post radioligand therapy. PSMA uptake in the salivary glands was evaluated using SPECT/CT imaging.

The investigators reported that the cohort received 1 to 2 cycles of treatment with 

Ac (6.87 ± 3.14 MBq) per cycle, and received a total of 16 IncoA treatments. The cohort was heavily pretreated, with “a median PSA [prostate-specific antigen] level of 59 [ng/mL] (range, 17.2 [ng/mL] to 2130.0 [ng/mL]) and a mean Karnofsky performance score of 85.0 ± 11.6,” according to the abstract. Four patients in the cohort received only IncoA; the remaining patients received both IncoA and scopolamine patches.

When comparing the IncoA-treated parotid glands with the opposite parotid gland, investigators reported a mean 30% reduction in PSMA uptake in the IncoA-treated glands. With the submandibular glands, a mean 17% reduction in PSMA uptake was observed in the IncoA-treated glands vs the opposite glands. The regimen was found to be well tolerated, with no serious or systemic adverse events reported. In addition, there was no discontinuation of PSMA treatment due to dry mouth.

“This study demonstrates that Botox, administered at recommended doses in combination with a nausea patch, offers a promising therapeutic strategy for reducing radiation-induced salivary gland toxicity without compromising PSMA tumor uptake,” said Jingjing Zhang, MD, PhD, assistant professor at the Theranostics Centre of Excellence in the Yong Loo Lin School of Medicine at the National University of Singapore, in the news release. “The significance of this work lies in its direct patient benefit and its potential to expand the therapeutic utility of PSMA radiopharmaceutical therapy, particularly with alpha-emitting radionuclides like 

1. Zhao T, Mueller J, Fan X, Jakobsson V, Zhang J, Baum RP. Botulinum toxin plus scopalamine as a protective strategy against salivary gland toxicity in patients treated with 225Ac- and 177Lu- PSMA-targeted radioligand therapy (TANDEM PSMA-RLT). 

2. Botox mitigates debilitating dry mouth in prostate cancer patients receiving radiopharmaceutical therapy. Society of Nuclear Medicine and Molecular Imaging. June 24, 2025. Accessed June 25, 2025. https://www.eurekalert.org/news-releases/1088797

Botulinum toxin (IncoA, Xeomin) combined with an anti-nausea patch effectively reduces salivary gland toxicity in metastatic prostate cancer patients undergoing PSMA-directed radiopharmaceutical therapy. This approach results in a 30% decrease in PSMA uptake by the salivary glands without affecting treatment efficacy. The study involved 14 patients, with IncoA injections and scopolamine patches administered before radioligand therapy. The treatment was well tolerated, with no serious adverse events or treatment discontinuations due to dry mouth, highlighting its potential to enhance PSMA radiopharmaceutical therapy's therapeutic utility.

The approach was associated with a 30% decrease in PSMA uptake by the salivary glands without compromising the treatment’s efficacy.

Jeremie Calais, MD, PhD

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