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"The good news is that women have been entering medicine in increasing numbers for more than three decades. The not-so-good news is that women are still underrepresented and underutilized in positions of power," writes Deborah M. Shlian, MD, MBA.

Despite overall gains, leadership and payment gaps remain for women in medicine

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

Telix Pharmaceuticals has resubmitted a biologics license application (BLA) to the FDA to support approval of TLX250-CDx (Zircaiz; 

Zr-DFO-girentuximab) for imaging in clear cell renal cell carcinoma (ccRCC), the company announced in a news release.

“We are pleased to be progressing the BLA for TLX250-CDx, which has been granted Breakthrough designation, and may therefore be eligible for priority review,” said Kevin Richardson, CEO of Precision Medicine at Telix, in the news release.

 “Telix continues to target a full US commercial launch in 2025 addressing a major unmet medical need for patients with suspected ccRCC.”

According to the company, a PDUFA date is expected to be issued following the 60-day administrative review of the application.

The BLA was initially submitted to the FDA in June 2024. In addition to the BLA, Telix also requested priority review for TLX250-CDx, which would expedite the review time for the agent, if granted. The agent was previously awarded a rolling review process based on a breakthrough therapy designation granted in July 2020.

However, in their review of the initial application, the agency issued a complete response letter, citing an issue in the Chemistry, Manufacturing, and Controls package.

 Specifically, they noted concerns in the demonstration of adequate sterility assurance during dispensing of TLX250-CDx in the radiopharmacy production environment.

On this, the company commented in the news release, “Telix can confirm that despite this concern raised by the FDA, all Process Performance Qualification (PPQ) batches submitted as part of the BLA application passed the sterility requirements of product release.”

The FDA did not identify any issues regarding the clinical and nonclinical safety and efficacy data for the agent.

The BLA submission for TLX250-CDx is supported by findings from the phase 3 ZIRCON trial (NCT03849118), which met all co-primary and secondary end points by demonstrating high specificity and sensitivity of the agent for PET/CT imaging of ccRCC.

Overall, data from the trial showed that the agent had an average sensitivity of 86% and an average specificity of 87% across 3 independent readers in detecting ccRCC in patients with an indeterminate renal mass. Further, the agent demonstrated a positive predictive value of 93% for ccRCC, including in small and difficult to detect lesions.

A secondary outcome analysis of patients with small masses (defined as 4 cm or less; cT1a) showed an average sensitivity of 85.5% and an average specificity of 89.5% with the agent. For both primary and secondary end points, the lower bounds of the 95% confidence intervals exceeded 75% across all readers.

Regarding safety, there were 263 adverse events (AEs) experienced among 124 patients. Of those, 2 AEs of mild intensity were determined to be related to treatment.

In total, the open-label, multi-center ZIRCON study enrolled 300 adult patients with ccRCC who were scheduled for partial or total nephrectomy. Of those, 284 evaluable patients were included in the primary analysis. The mean age of patients in the trial was 62.

All patients included in the study were given a single dose of TLX250-CDx IV (10 mg girentuximab) on day 0 and underwent PET/CT imaging on day 5 (± 2 days). The co-primary outcome measures were sensitivity and specificity of TLX250-CDx in detecting ccRCC in patients with an indeterminate renal mass.

Currently, TLX250-CDx is available through an expanded access program in the United States, named patient programs in Europe, and a special access scheme in Australia for patients outside of clinical trials for whom there is no comparable or satisfactory alternatives. If approved, TLX250-CDx would be the first commercially available targeted radiopharmaceutical imaging agent specifically for kidney cancer in the United States.

1. Telix files TLX250-CDx (Zircaix) BLA for kidney cancer imaging. News release. Telix Pharmaceuticals Limited. December 30, 2024. Accessed January 2, 2025. https://telixpharma.com/news-views/telix-files-tlx250-cdx-zircaix-bla-for-kidney-cancer-imaging/

2. BLA filing update for renal cancer imaging agent TLX250-CDx. News release. Telix Pharmaceuticals. July 31, 2024. Accessed January 2, 2025. chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://company-announcements.afr.com/asx/tlx/6f71b977-4ecf-11ef-a765-2af604e39195.pdf

3. Shuch BM, Pantuck AJ, Bernhard JC, et al. 89Zr-DFO-girentuximab for PET/CT imaging of clear cell renal cell carcinoma – results from a phase 3 ZIRCON study. Presented at: 2023 ASCO Genitourinary Cancers Symposium. San Francisco, California. LBA602. https://ascopubs.org/doi/10.1200/JCO.2023.41.6_suppl.LBA602

Telix Pharmaceuticals has resubmitted a biologics license application to the FDA for TLX250-CDx, a radiopharmaceutical imaging agent for clear cell renal cell carcinoma (ccRCC). The application, initially submitted in June 2024, faced a complete response letter due to sterility assurance concerns, though clinical and nonclinical data were not questioned. Supported by the phase 3 ZIRCON trial, TLX250-CDx demonstrated high sensitivity and specificity in PET/CT imaging of ccRCC. If approved, it would be the first targeted radiopharmaceutical imaging agent for kidney cancer in the U.S.

The BLA for TLX250-CDx was initially submitted to the FDA in June 2024. 

TLX250-CDx BLA resubmitted to FDA for kidney cancer  

The FDA has approved nivolumab (Opdivo) plus hyaluronidase-nvhy (Qvantig) for subcutaneous injection across 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 was previously approved under several indications in renal cell carcinoma (RCC) and urothelial carcinoma. 

The approval is supported by findings from the phase 3 CheckMate-67T trial (NCT04810078), in which subcutaneous nivolumab plus hyaluronidase-nvhy met the study’s co-primary end points by demonstrating noninferiority to IV nivolumab regarding time average nivolumab serum concentration over 28 days (C

For both pharmacokinetic end points, the predefined acceptance margin was met, with the lower boundary of the 90% confidence interval of geometric mean ratios not reaching less than 0.8.

Data from the study, which were presented earlier this year 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, patients in 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) among patients in the IV arm.

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 hyaluronidase-nvhy 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.

 of subcutaneous nivolumab vs IV nivolumab. The key secondary end point was ORR per BICR.

The CheckMate-67T remains ongoing, with final completion expected in January 2026.

Subcutaneous nivolumab plus hyaluronidase-nvhy are approved across most previously approved adult solid tumor indications for nivolumab, including several in RCC and urothelial carcinoma.

In RCC, subcutaneous nivolumab is approved for the first-line treatment of patients with intermediate- or poor-risk advanced RCC following treatment with intravenous (IV) nivolumab and ipilimumab combination therapy, in combination with cabozantinib for the first-line treatment of patients with advanced RCC, and in the treatment of patients with advanced RCC who have received prior anti-angiogenic therapy. Subcutaenous nivolumab is not approved in combination with ipilimumab for the treatment of patients with RCC. 

In urothelial carcinoma, the subcutaneous nivolumab formulation is indicated for the treatment of patients with urothelial carcinoma who are at high risk of recurrence following radical tumor resection, in locally advanced or metastatic urothelial carcinoma in patients that have progressed during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy, and  in combination with cisplatin and gemcitabine for the first-line treatment of patients with unresectable or metastatic urothelial carcinoma.

1. FDA approves nivolumab and hyaluronidase-nvhy for subcutaneous injection. News release. Published online and accessed December 27, 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nivolumab-and-hyaluronidase-nvhy-subcutaneous-injection

2. 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. 

3. 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 December 27, 2024. https://clinicaltrials.gov/study/NCT04810078

4. U.S. Food and Drug Administration approves Opdivo

Qvantig (nivolumab and hyaluronidase-nvhy) injection, for subcutaneous use in most previously approved adult, solid tumor Opdivo (nivolumab) indications. News release. Bristol Myers Squibb. Published online and accessed December 27, 2024. https://www.businesswire.com/news/home/20241218841283/en/U.S.-Food-and-Drug-Administration-Approves-Opdivo-Qvantig%E2%84%A2-nivolumab-and-hyaluronidase-nvhy-Injection-for-Subcutaneous-Use-in-Most-Previously-Approved-Adult-Solid-Tumor-Opdivo%C2%AE-nivolumab-Indications12

The FDA has approved the combination of nivolumab and hyaluronidase-nvhy for subcutaneous injection across all previously approved solid tumor indications for nivolumab. This approval is based on the phase 3 CheckMate-67T trial, which demonstrated noninferiority of subcutaneous administration compared to intravenous administration in terms of pharmacokinetics and objective response rate. The safety profile of the subcutaneous formulation was consistent with the intravenous version, with low-grade injection-site reactions. The trial enrolled 495 patients with advanced or metastatic clear cell renal cell carcinoma and remains ongoing.

The approval is supported by data from the phase 3 CheckMate-67T trial.

FDA approves subcutaneous nivolumab for solid tumors, including RCC

In 2024, the FDA authorized many new treatments and devices for urology practice. Here are the highlights.    

Erdafitinib for FGFR3-positive urothelial carcinoma

The FDA granted full approval to erdafitinib (Balversa) for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma with susceptible 

 genetic alterations whose disease has progressed on or after at least 1 line of prior systemic therapy, according to the FDA. The treatment is not recommended for patients who have not received treatment with PD-1/PD-L1 checkpoint inhibitors.

Erdafitinib previously received accelerated approval for the treatment of adult patients with FGFR2/3-positive locally advanced or metastatic urothelial carcinoma that has progressed on or after at least 1 line of platinum-containing chemotherapy, including 12 or fewer months of neoadjuvant or adjuvant platinum-containing chemotherapy.

Transitioning an accelerated FDA approval into a full approval requires verification of the treatment’s clinical benefit in a confirmatory trial. The confirmatory trial supporting the full approval for erdafitinib was the phase 3 THOR trial (NCT03390504), which showed that erdafitinib significantly improved overall survival compared with investigator’s choice of chemotherapy in patients with 

-altered metastatic urothelial cancer who had previously received an anti–PD-(L)1 therapy.

Cefepime/enmetazobactam for complicated UTI

The FDA approved cefepime/enmetazobactam (Exblifep) for treating complicated urinary tract infections (cUTIs), including pyelonephritis, according to a news release from Allecra Therapeutics, which maintains sole responsibility for the therapy.

The FDA has also granted Allecra a 5-year marketing exclusivity extension for cefepime/enmetazobactam as part of the Generating Antibiotic Incentives Now (GAIN) Act. The GAIN Act provides benefits to manufacturers of qualified infectious disease products to encourage the creation of anti-infective therapeutics.

The FDA approval is supported by data from the phase 3 ALLIUM trial (NCT03687255), which demonstrated the noninferiority and superiority of cefepime/enmetazobactam vs piperacillin/tazobactam regarding the primary composite outcome measure of clinical cure and microbiological eradication in patients with cUTIs.

Nivolumab plus cisplatin/gemcitabine in urothelial carcinoma

The FDA approved nivolumab (Opdivo) in combination with frontline cisplatin and gemcitabine for the treatment of adult patients with unresectable or metastatic urothelial carcinoma.

 The approval is based on data from the phase 3 CheckMate901 trial (NCT03036098), which demonstrated improved overall survival (OS) and progression-free survival with the nivolumab-combination therapy vs cisplatin/gemcitabine alone in this patient population.

At a median follow-up of 33 months, nivolumab in combination with cisplatin and gemcitabine, followed by nivolumab maintenance therapy, led to a 22% reduction in the risk of death, demonstrating a median OS of 21.7 months (95% CI, 18.6-26.4) vs 18.9 months (95% CI, 14.7-22.4) with cisplatin and gemcitabine alone (HR, 0.78; 95% CI, 0.63, 0.96; 

The FDA granted 510(k) clearance to the ultrasound bladder scanner EdgeFlow UH10, announced Edgecare, the technology developer, in a news release.

 According to Edgecare, the EdgeFlow UH10 bladder scanner utilizes high-resolution ultrasound imaging to measure postvoid residual urine in the bladder noninvasively. The scanner offers a volume measurement range of 0 to 999 mL, with accuracy plus or minus 7.5% (over 100 mL).

The device is equipped with DualActive probe technology, which allows simultaneous scanning of the bladder’s traverse and sagittal planes with 1 scan. Additionally, the tool incorporates deep learning artificial intelligence (AI)–powered LiveContour and MaxContour technologies to quickly identify the bladder and provide fast calculations of accurate measurement values of maximum bladder volume.

The device also offers a lightweight and compact design that facilitates portability. The total weight of the console and probe is 419 g.

The FDA granted 510(k) clearance to the RenaFlex single-use flexible ureteroscope system for treating patients with urinary diseases such as kidney stones, announced Olympus, the system developer, in a news release.

 The RenaFlex ureteroscope system is intended for accessing and visualizing the urinary tract (the urethra, bladder, ureter, calyces, and renal papillae) via transurethral or percutaneous access routes. The ureteroscope is designed to work with the compatible CV-S1 video system center for flexible single-use endoscopes.

Nogapendekin alfa inbakicept plus BCG for NMIBC

The FDA approved N-803 (Anktiva, nogapendekin alfa inbakicept-pmln), a first-in-class IL-15 receptor agonist immunotherapy, for use in combination with BCG for the treatment of patients with BCG-unresponsive non–muscle invasive bladder cancer (NMIBC) with carcinoma in situ with or without papillary tumors, announced ImmunityBio, the developer of the therapy, in a news release.

The approval is supported by findings from cohort B of the ongoing phase 2/3 QUILT-3.032 trial (NCT03022825), assessing BCG in combination with N-803 in patients with BCG-unresponsive, high-grade Ta/T1 papillary NMIBC. Patients in cohort B received N-803 in combination with BCG maintenance therapy for up to 37 months.

Data from the trial have shown a complete response (CR) of 62% to 73% among the 77 evaluable patients included in the analysis. At the time of the data cutoff, the duration of CR was longer than 47 months, exceeding the threshold for meaningful clinical results per a panel of experts at the International Bladder Cancer Group.

Pivmecillinam tablets for uncomplicated UTIs

The FDA approved oral pivmecillinam (Pivya) tablets for the treatment of adult female patients with uncomplicated UTIs (uUTIs) caused by susceptible isolates of 

 The antibiotic’s approval is based on data from 3 clinical trials evaluating the efficacy of different pivmecillinam dosing regimens compared with placebo, another oral antibacterial drug, or ibuprofen. These studies all enrolled adult female patients with uUTIs.

The FDA granted 510(k) clearance to the Contouring Assistant, a machine-learning–based prostate segmentation tool designed for use in conjunction with the TULSA-PRO system to assist in delineating the prostate and target ablation volume for transurethral ultrasound ablation (TULSA) procedure treatment planning.

 The Contouring Assistant utilizes a large database of successful physician-created TULSA treatment designs to recommend a treatment plan based on learned patterns. Specifically, the tool uses 24,611,072 parameters extracted from 7466 training images.

The FDA granted 510(k) clearance to Yōni.Fit Bladder Support, a vaginal insert for adult patients with urine leakage due to stress urinary incontinence (SUI), announced Watkins-Conti Products, the developer of the device, in a news release.

Yōni.Fit is a soft vaginal insert intended to reduce urine leakage due to SUI without interfering with voluntary urination. The device is self-administered and can be used during activity or for up to 12 hours for general symptom control.

The FDA clearance of the device was supported by findings from a randomized, controlled trial (NCT03978741) that evaluated the efficacy, user acceptance, safety, and tolerability of the Yōni.Fit device vs a comparator device for the temporary management of SUI.

Overall, data from the study showed that a significantly higher percentage of patients experienced a clinically meaningful reduction in 12-hour pad weights with the Yōni.Fit device than with the comparator device (53.0% vs 23.3%; 

 =.013; absolute difference, 29.6%; 95% CI, 7.4%-51.8%).

FoundationOneLiquid CDx for niraparib/abiraterone in mCRPC

The FDA approved the liquid biopsy test FoundationOneLiquid CDx for use as a companion diagnostic in identifying patients with BRCA-positive metastatic castration-resistant prostate cancer (mCRPC) who may benefit from treatment with niraparib and abiraterone acetate dual action tablets (Akeega), Foundation Medicine announced in a news release.

This announcement follows an earlier FDA decision to approve the company’s tissue-based comprehensive genomic profiling test FoundationOne CDx as a companion diagnostic for the same therapy and indication in August 2023.

 Niraparib and abiraterone acetate is a dual-action tablet approved for the treatment of adult patients with deleterious or suspected deleterious 

The FDA granted 510(k) clearance to an expanded indication of the Senhance Surgical System for use in adult and pediatric patients undergoing urologic procedures, announced Asensus Surgical, the device developer, in a news release.

 According to Asensus, the Senhance Surgical System is a digital laparoscopy system “intended to assist in the accurate control of laparoscopic instruments for visualization and endoscopic manipulation of tissue including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, mobilization, and retraction.”

The device utilizes augmented intelligence and deep learning technologies to increase surgeon control and reduce variability, making it the first intraoperative augmented intelligence technology approved for robotic surgery, the company noted.

AI-powered robotic system for Aquablation therapy

The FDA granted 510(k) clearance to the HYDROS robotic system, an AI-powered platform designed to enhance the delivery of Aquablation therapy for patients with benign prostatic hyperplasia, PROCEPT BioRobotics, the developer of the platform, announced in a news release.

 According to the company, key features of the HYDROS robotic system include FirstAssist AI treatment planning, advanced image guidance, robotic resection, and a streamlined workflow. FirstAssist AI is built on data from over 50,000 real-world Aquablation procedures and uses image recognition software to provide an optimal treatment plan for each patient. The system integrates ultrasound and cystoscopy images to offer a multidimensional view of the entire prostate, enabling individualized treatment planning based on patients’ anatomy.

Companion diagnostic for olaparib/abiraterone in BRCA+ mCRPC

The FDA approved the tissue-based FoundationOne CDx and blood-based FoundationOneLiquid CDx tests for use as companion diagnostics in identifying patients with deleterious or suspected deleterious 

-mutated mCRPC who may benefit from treatment with olaparib (Lynparza) in combination with abiraterone acetate (Zytiga) and prednisone or prednisolone, Foundation Medicine announced in a news release.

The FDA granted 510(k) clearance to Ambu’s HD cystoscopy solution, consisting of the company’s HD single-use cystoscope, the Ambu aScope 5 Cysto HD, and its 2 full-HD endoscopy systems, Ambu aView 2 Advance and Ambu aBox 2, the company announced in a news release.

In October 2023, the cystoscopy solution was granted a CE mark for regulatory clearance in Europe. The company is planning a commercial launch of the solution in the US, designed to support urologists performing diagnostic and therapeutic ureteroscopy procedures.

The FDA has granted approval to oral sulopenem (sulopenem etzadroxil and probenecid; Orlynvah) for the treatment of uUTIs caused by the designated microorganisms 

 in adult women who have limited or no alternative oral antibacterial treatment options, Iterum Therapeutics announced in a news release.

 According to the company, oral sulopenem is the first oral penem approved for use in the US.

The approval is supported by data from the phase 3 SURE 1 (NCT03366207) and REASSURE (NCT05584657) trials. In SURE 1, oral sulopenem demonstrated superiority over ciprofloxacin in the treatment of patients with fluoroquinolone-resistant infections and noninferiority to ciprofloxacin in the treatment of patients with a quinolone-susceptible uropathogen. In REASSURE, the oral penem demonstrated noninferiority to oral amoxicillin/clavulanate in treating patients with uUTI.

The FDA has granted de novo clearance to the Stone Clear device, which delivers non-invasive ultrasound pulses to patients to facilitate passage of residual kidney stone fragments post-lithotripsy, SonoMotion announced in a news release.

In 2024, the FDA approved several new treatments and devices for urology, including erdafitinib for FGFR3-positive urothelial carcinoma, cefepime/enmetazobactam for complicated UTIs, and nivolumab with cisplatin/gemcitabine for urothelial carcinoma. The EdgeFlow UH10 bladder scanner and RenaFlex ureteroscope system received clearance, while the AI-powered Contouring Assistant and Yōni.Fit Bladder Support were also approved. Other notable approvals include the FoundationOneLiquid CDx for mCRPC, the HYDROS robotic system for Aquablation therapy, and the NanoKnife System for prostate tissue ablation.

Catch up on all the notable drug and device approvals in urology over the past year.  

Deborah M. Shlian, MD, MBA

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