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

The expanded labeling would enable the use of flibanserin to treat hypoactive sexual desire disorder in postmenopausal women. 

FDA grants priority review to expanded indication of flibanserin in HSDD

The new advanced annotation workflow on the UroNav System is designed to work in tandem with DynaCAD Urology to support focal therapy planning.

FDA clears image-guided navigation platform for focal therapy in prostate cancer

The code, 0991T, will become effective on January 1, 2026. 

Category III CPT code issued for Enhanced Lithotripsy System 

 is compliance officer and medical director of coding and reimbursement, United Urology Group and Chesapeake Urology, in Towson, Maryland.

"As always, we encourage you to communicate among all team members and pay attention to your documentation," write Jonathan Rubenstein, MD, and Mark Painter.

When to report 50320 with 49187 for nephrectomy procedures

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Patient data is so valuable — and smaller providers are more vulnerable — that hackers are increasingly targeting physician groups. 

Smaller medical practices increasingly targeted for cyber attacks

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

On July 17, 2025, the FDA convened a panel of experts to discuss the use of hormone replacement therapy (HRT) in menopausal women.

These experts urged the agency to remove the current boxed warning on vaginal estrogen products that says the medication carries a risk of serious adverse effects. The panelists, who were selected by FDA commissioner Marty Makary, MD, MPH, outlined data showing that these risks may be overstated, leading women to avoid estrogen-containing products out of fear of its risks.

Makary, who has voiced support for the use of HRT, began the discussion by highlighting data showing that the benefits of the medication appear to outweigh the risks. In his opening remarks, he cited data from the 1950s showing early heart disease in women who had their ovaries removed, which “[suggests] a powerful and profound cardio-protective effect of estrogen made in the ovaries,” he noted.

He went on to highlight subsequent data showing that “when a woman starts estrogen or estrogen plus progesterone within 10 years of the onset of menopause, there's somewhere between a 25% and 50% reduction in fatal heart attacks and cardiovascular disease. To put that in context, that is comparable to the risk reduction or greater than the risk reduction of a statin.”

The agency then heard remarks from several prominent experts across urology, women’s health, endocrinology, gynecology, and neuroscience, who highlighted the growing consensus among these fields in the benefits of menopausal hormone therapy when used appropriately.

Heather Hirsch, MD, MS, NCMP, a board-certified internist, opened the discussion by emphasizing the importance of distinguishing between systemic and local estrogen.

“Vaginal or local estrogen is categorically safe for all women, period, because it does not travel systemically,” she explained. “What we know is that it does not increase the risks of heart attacks, breast cancers, or strokes—no data shows that. However, there is a boxed warning inappropriately affirming that it does.”

Hirsch argued that misinformation, compounded by a lack of provider education, is actively harming women. She called on the FDA to remove the boxed warning on vaginal estrogen products to help restore clinician confidence in prescribing HRT.

Barbara Levy, MD, FACOG, FACS, MSCP, a clinical professor of obstetrics and gynecology – George Washington University School of Medicine & Health Sciences, echoed Hirsch’s remarks that the specifics of administration matter—particularly the route of administration and the dose administered.

She pointed out that the hormone products used in the Women’s Health Initiative (WHI) study—which led to the original boxed warning on estrogen products—were highly specific, and their risks should not be applied broadly to all HRT.

“It’s inappropriate scientifically to conflate the results in a study that used conjugated equine estrogen to all forms of hormone therapy,” Levy noted. “That’s a disaster that we’ve been perpetrating for decades now.”

The need for greater education, awareness

Rachel S, Rubin, MD, a board-certified urologist fellowship trained in sexual medicine, called for greater awareness and updated messaging around treatments for women’s urologic health.

“Science evolves and so must our warning labels,” said Rubin. “Local vaginal hormones, estrogen and DHEA, are not only similar to, but actually way better than Viagra, because not only do they help with sex and its urinary symptoms, they prevent urinary tract infections. This guideline-supported fact says that we can prevent more than 50% of people's urinary tract infections with local vaginal hormones, and we have known this for decades. Why haven't you heard of this before? Because your doctor doesn't know this either, and because women's health has a marketing problem.”

Collectively, the panelists argued that hormone therapy has a strong risk-benefit profile when started appropriately and monitored. Yet many women continue to go without needed care—largely due to gaps in clinician education, confusing regulations, and persistent fears rooted in outdated or overstated risks.

In a unified call to action, the panel urged the FDA to revise or remove the boxed warning on low-dose vaginal estrogen, calling it a critical step toward improving care for menopausal women.

Hirsch concluded, “Women deserve policy that reflects the current evidence and not outdated myths.”

1. FDA Expert Panel on Menopause and Hormone Replacement Therapy for Women. YouTube: US Food & Drug Administration. July 17, 2025. Accessed July 18, 2025. https://www.youtube.com/watch?v=_2ZRlOivC5M

A panel of experts convened by the FDA discussed the use of hormone replacement therapy (HRT) in menopausal women, advocating for the removal of the black box warning on vaginal estrogen products. The panelists presented data suggesting that the risks associated with these products, such as breast cancer and cardiovascular issues, may be overstated. They emphasized the benefits of HRT, particularly when initiated within ten years of menopause onset, and highlighted the safety of local vaginal estrogen. The panel urged the FDA to update warning labels to reflect current evidence.

In a panel meeting convened by the FDA, experts urged the agency to revise or remove the outdated boxed warning on hormone therapies for menopause.

Experts urge FDA to remove black box warning on low-dose vaginal estrogen 

The education of physicians in the US currently falls into 2 pathways: allopathic (for an MD degree) and osteopathic (for a DO degree). Over the past 10 years, the number of students graduating from osteopathic programs has increased by approximately 3000, representing a growing percentage of the physician workforce.

 Based on 2024 Association of American Medical Colleges data, osteopathic physicians comprise approximately 11.5% of the 1,010,892 actively practicing doctors.

 An even smaller percentage of these physicians pursue a career in urology, with an estimated 3.0% of the 10,747 practicing urologists having a DO degree.

Discrepancies between the 2 training pathways extend beyond residency, with differences in both practice patterns and physician demographics. Research across various specialties and with diverse cohort sizes has demonstrated that osteopathic physicians are more likely to practice in rural areas compared with their allopathic counterparts.

 For example, Gronbeck et al analyzed the practice trends of DO and MD dermatologists nationally and found that a significantly higher proportion of osteopathic dermatologists worked in low-income, nonmetropolitan areas with a relative shortage of dermatologists compared with the population.

 Given this context, our current study hypothesized that DO urologists differ significantly from their allopathic counterparts regarding their demographic background, fellowship training, and practice patterns.

To test this hypothesis, we reviewed American Urological Association (AUA) Census data from 2018 to 2022 to compare the aforementioned variables of demographics, training, and clinical practice information between osteopathic and allopathic urologists.The AUA Census is a voluntary annual survey created by the AUA Data Committee that is distributed to all AUA members, in addition to any urologists who have participated in AUA educational courses or annual meetings. The survey includes questions on respondents’ background, education, and practice settings. To address the discrepancy in sample sizes between the 2 cohorts, we analyzed the 2022 data for allopathic urologists (n=1849) alongside the information for osteopathic urologists from 2018 to 2022 (n=154), thereby maximizing the sample size and available data for the DOs. A χ2 analysis was used to evaluate for significant differences between cohort responses.

A greater proportion of osteopathic urologists were female compared with the allopathic group (26.0% vs 17.4%, respectively; 

 = .008). Additionally, osteopathic urologists were more likely to pursue general urology compared with fellowship training (65.6% vs 53%; 

 = .003). Lastly, osteopathic urologists were more likely to work in private practice (58.4% vs 49.8%; 

 = .038) and in rural/nonmetropolitan areas (16.2% vs 8.7%; 

This study examined potential differences in physician demographics, fellowship training, and practice patterns between MD and DO urologists. The DO cohort was significantly smaller than the MD cohort, even when combining 5 consecutive years of DO cohort data. DO urologists were more likely to pursue general urology rather than additional fellowship training, and they tended to practice more frequently in private settings as well as in rural and nonmetropolitan areas. Additionally, our data showed a higher proportion of female DO urologists. 

The disparity in DO and MD cohort sizes is linked to organizational changes that have affected DO applicant participation in the urology match. Before the transition to single accreditation of US graduate medical education in 2020, there were only 11 urology residency programs participating in the American Osteopathic Association (AOA) match, with 22 intern positions offered annually.

 To evaluate urology residency admissions since the merger, each publicly available residency program website was reviewed, and the reported medical degrees of residents were recorded. Based on these data, 6 out of the 11 formerly AOA programs (54.5%) have accepted MD residents. Excluding the 6 urology programs established since 2020 and former AOA programs, 41 out of 131 (31.3%) allopathic programs have accepted DO residents. Most recently, in the 2025 urology match, only 30 DO applicants successfully secured positions out of the 403 available vacancies (7.4%).

 Overall, these trends continue to support a lower entry rate of osteopathic physicians into the field of urology, the reasons for which are likely multifactorial and warrant further attention and characterization.

Given the bottleneck effect of DO students who successfully match into urology residency, it is not surprising that a similar effect can be seen regarding fellowship training. The present study shows that significantly fewer DO urologists pursue fellowships, and

 although the literature on why this exists in urology is sparse, possible causes can be extrapolated from similarly competitive surgical subspecialty studies. Orthopedic adult reconstruction fellowship match data from 2012-2023 found that DO graduates were ranked lower by programs and were significantly less likely to match than their MD counterparts.

 DO urologists may also decide not to pursue fellowship to provide comprehensive general urology care to smaller rural communities. Osteopathic medical schools place a high priority on rural health care access, with 56% of osteopathic schools intentionally located in health professional shortage areas designated by the federal government.

 This principle may continue to guide practice patterns as DO urologists more commonly practice in rural areas of the US.

Studies analyzing AUA Census data have begun to show that planned earlier retirement age and decreased productivity of practicing urologists will intensify the existing shortage.

In particular, a 2022 study examining the rural urology workforce showed that 76.1% of respondents were older than 55

 and only 31.9% planned to be in the same practice with the same clinical volume in 5 years.

 With 63% of American counties having no practicing urologists when these data were published, it is reasonable to estimate that the decreasing workforce will continue to be a concern for access to urologic care across the country, particularly in rural communities. Appreciating the unique practice niche that osteopathic urologists serve is thus critical in strategizing to address projected subspecialty workforce needs.

This study is not without limitations. Our data are based on voluntary AUA Census participation. Therefore, responses only make up a percentage of the urology workforce and may not accurately reflect the entire population. Another limitation is the considerable difference in sample sizes between the MD and DO cohorts, which necessitated the aggregation of DO data for comparison with current allopathic information. This methodology introduces potential bias and can affect the generalizability of the results.

The current study uses AUA Census data to highlight significant differences between contemporary DO and MD urologists. The results indicate DO urologists are more likely to practice as generalists and in rural/nonmetropolitan areas; additionally, there is a relatively higher proportion of female osteopathic urologists compared to their allopathic counterparts. Despite the overall underrepresentation of osteopathic urologists in the field, they play a crucial role in providing care in regions that lack subspecialty services. Further research is needed to validate these significant workforce trends among MD and DO practitioners in contemporary and comparably adjusted cohorts.

Osteopathic physicians are increasingly contributing to the US physician workforce, yet they remain underrepresented in urology. DO urologists are more likely to practice general urology, work in rural areas, and are more often female compared to their allopathic counterparts. The transition to a single accreditation system has affected DO participation in urology residencies, contributing to fewer DOs pursuing fellowship training. Despite these challenges, DO urologists play a vital role in underserved areas, highlighting the need for further research to understand and address these workforce trends.

"Osteopathic urologists were more likely to work in private practice (58.4% vs 49.8%; P = .038) and in rural/nonmetropolitan areas (16.2% vs 8.7%; P = .002)," write the authors. 

Is there a difference between MD and DO in urology?

Data from both cohorts of the phase 3 TALAPRO-2 trial (NCT03395197) have been published in concurrent publications in 

, looking at the combination of talazoparib (Talzenna) plus enzalutamide (Xtandi) in patients with homologous recombinant repair (HRR)-deficient metastatic castration-resistant prostate cancer (mCRPC)

 and in those unselected for HRR gene mutations.

In both cohorts, the combination of talazoparib plus enzalutamide led to a significant improvement in overall survival (OS) vs enzalutamide alone.

In June 2023, the combination of talazoparib plus enzalutamide was FDA approved for patients with HRR-gene mutated mCRPC based on findings from the TALAPRO-2 trial.

"In the final overall survival analysis, the trial demonstrated an unprecedented 14-month improvement in OS and a nearly 40% reduction in the risk of death when talazoparib was added to enzalutamide in mCRPC patients with HRR gene mutations," commented TALAPRO-2 co-author Neeraj Agarwal, MD, FASCO, in correspondence with 

The FDA recently declined to approve an expanded indication for the combination for broader use in the treatment of patients with mCRPC who do not harbor HRR gene mutations.

negative vote from the FDA’s Oncologic Drugs Advisory Committee

 (ODAC), where the committee unanimously voted 0-8 against a favorable risk-benefit profile for the combination in patients without HRR gene mutations. The FDA sided with ODAC in their decision on Pfizer’s supplemental new drug application, noting that the TALAPRO-2 data were insufficient to support an expanded label in the subgroup of patients with non-HRR gene-mutated mCRPC.

The phase 3 TALAPRO-2 trial evaluated the combination of talazoparib and enzalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC), both with and without homologous recombinant repair (HRR) gene mutations. The combination significantly improved overall survival (OS) compared to enzalutamide alone in both cohorts. The FDA approved the combination for HRR-gene mutated mCRPC but declined broader approval for unselected patients due to insufficient data. The trial demonstrated notable benefits in patients with BRCA1/2 alterations and maintained a consistent safety profile, with anemia and neutropenia as common adverse events.

In both cohorts, the combination of talazoparib plus enzalutamide led to a significant improvement in overall survival vs enzalutamide alone.

Michael Parisi

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