Johnson & Johnson receives U.S. FDA Priority Review for TAR-200 NDA in high-risk non-muscle invasive bladder cancer
Johnson & Johnson (NYSE: JNJ) announced that the FDA has granted Priority Review for TAR-200, an innovative intravesical drug releasing system for treating high-risk non-muscle invasive bladder cancer (HR-NMIBC) in patients who are unresponsive to BCG therapy.
The Phase 2b SunRISe-1 study demonstrated impressive results with an 82.4% complete response rate, and 52.9% of patients remaining cancer-free for at least one year. TAR-200 represents the first significant innovation in bladder cancer drug delivery in over 40 years, providing sustained local treatment delivery over three weeks per cycle.
The treatment can be administered in an outpatient setting in under five minutes, requiring no general anesthesia or additional monitoring.
Johnson & Johnson (NYSE: JNJ) ha annunciato che la FDA ha concesso la Revisione Prioritaria per TAR-200, un innovativo sistema di rilascio intravescicale di farmaci per il trattamento del carcinoma della vescica non muscolo-invasivo ad alto rischio (HR-NMIBC) in pazienti non responsivi alla terapia con BCG.
Lo studio di Fase 2b SunRISe-1 ha mostrato risultati impressionanti con un tasso di risposta completa dell'82,4% e il 52,9% dei pazienti rimasti liberi da cancro per almeno un anno. TAR-200 rappresenta la prima innovazione significativa nella somministrazione di farmaci per il cancro della vescica in oltre 40 anni, offrendo un trattamento locale prolungato per tre settimane per ciclo.
Il trattamento può essere somministrato in regime ambulatoriale in meno di cinque minuti, senza necessità di anestesia generale o monitoraggio aggiuntivo.
Johnson & Johnson (NYSE: JNJ) anunció que la FDA ha otorgado la Revisión Prioritaria para TAR-200, un innovador sistema de liberación intravesical de fármacos para el tratamiento del cáncer de vejiga no músculo invasivo de alto riesgo (HR-NMIBC) en pacientes que no responden a la terapia con BCG.
El estudio de Fase 2b SunRISe-1 mostró resultados impresionantes con una tasa de respuesta completa del 82,4% y un 52,9% de los pacientes libres de cáncer durante al menos un año. TAR-200 representa la primera innovación significativa en la administración de fármacos para el cáncer de vejiga en más de 40 años, proporcionando un tratamiento local sostenido durante tres semanas por ciclo.
El tratamiento puede administrarse de forma ambulatoria en menos de cinco minutos, sin necesidad de anestesia general ni monitoreo adicional.
Johnson & Johnson (NYSE: JNJ)는 FDA가 BCG 치료에 반응하지 않는 고위험 비근육침범 방광암(HR-NMIBC) 환자를 위한 혁신적인 방광 내 약물 방출 시스템인 TAR-200에 대해 우선 심사를 승인했다고 발표했습니다.
2b상 SunRISe-1 연구에서는 82.4%의 완전 반응률과 52.9%의 환자가 최소 1년간 암이 없는 상태를 유지하는 인상적인 결과를 보였습니다. TAR-200은 40년 넘게 방광암 약물 전달 분야에서 처음으로 중요한 혁신을 이루어, 3주간 지속되는 국소 치료를 제공합니다.
이 치료는 외래 환경에서 5분 이내에 투여할 수 있으며, 전신 마취나 추가 모니터링이 필요하지 않습니다.
Johnson & Johnson (NYSE : JNJ) a annoncé que la FDA a accordé une examen prioritaire pour TAR-200, un système innovant de libération intravésicale de médicament destiné au traitement du cancer de la vessie non invasif à haut risque (HR-NMIBC) chez les patients ne répondant pas à la thérapie BCG.
L'étude de phase 2b SunRISe-1 a démontré des résultats impressionnants avec un taux de réponse complète de 82,4% et 52,9% des patients restant sans cancer pendant au moins un an. TAR-200 représente la première innovation majeure dans la délivrance de médicaments pour le cancer de la vessie depuis plus de 40 ans, offrant un traitement local prolongé sur trois semaines par cycle.
Le traitement peut être administré en ambulatoire en moins de cinq minutes, sans nécessiter d'anesthésie générale ni de surveillance supplémentaire.
Johnson & Johnson (NYSE: JNJ) gab bekannt, dass die FDA eine Prioritätsprüfung für TAR-200 genehmigt hat, ein innovatives intravesikales Arzneimittelabgabesystem zur Behandlung von Hochrisiko-nicht muskelinvasivem Blasenkarzinom (HR-NMIBC) bei Patienten, die auf eine BCG-Therapie nicht ansprechen.
Die Phase-2b-Studie SunRISe-1 zeigte beeindruckende Ergebnisse mit einer vollständigen Ansprechrate von 82,4% und 52,9% der Patienten, die mindestens ein Jahr krebsfrei blieben. TAR-200 stellt die erste bedeutende Innovation in der Arzneimittelabgabe bei Blasenkrebs seit über 40 Jahren dar und bietet eine nachhaltige lokale Behandlung über drei Wochen pro Zyklus.
Die Behandlung kann ambulant in weniger als fünf Minuten verabreicht werden, ohne dass eine Vollnarkose oder zusätzliche Überwachung erforderlich ist.
- Achieved 82.4% complete response rate in Phase 2b trial
- 52.9% of patients remained cancer-free for one year or more
- FDA Priority Review status granted, potentially expediting approval
- First innovative drug delivery system for bladder cancer in 40 years
- Quick outpatient procedure requiring no anesthesia or monitoring
- Most patients experienced some adverse reactions, though mainly mild to moderate
- Limited to specific subset of bladder cancer patients who failed BCG therapy
Insights
FDA Priority Review for TAR-200 shows promising 82.4% complete response rate in bladder cancer, potentially transforming treatment landscape.
Johnson & Johnson's announcement of FDA Priority Review for TAR-200 represents a significant milestone in bladder cancer treatment. The intravesical drug releasing system (iDRS) shows an impressive
What makes TAR-200 particularly noteworthy is its novel drug delivery mechanism - the first innovation of its kind in over 40 years for high-risk non-muscle invasive bladder cancer (HR-NMIBC). Current treatment options for BCG-unresponsive patients are extremely limited, making this development especially valuable.
The system's design allows for sustained local delivery of gemcitabine directly into the bladder, where it remains for three weeks per treatment cycle. This localized approach likely contributes to the favorable safety profile observed, with primarily mild to moderate adverse reactions and notably no systemic adverse reactions reported - a substantial advantage over many cancer treatments.
The outpatient administration taking less than five minutes without requiring general anesthesia further enhances its clinical utility. For patients with BCG-unresponsive HR-NMIBC with carcinoma in situ, TAR-200 potentially offers a significant advancement in treatment options for a condition that has seen little therapeutic innovation in decades.
New Drug Application supported by results from the Phase 2b SunRISe-1 study
"TAR-200 represents an innovation in drug delivery that has not been seen in decades," said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Area Head, Oncology, Johnson & Johnson Innovative Medicine. "The FDA Priority Review for TAR-200 underscores our mission to fundamentally change the way urologists treat certain types of bladder cancer."
The regulatory submission is supported by data from the Phase 2b SunRISe-1 study, which demonstrated an 82.4 percent complete response (CR) rate with 52.9 percent of patients remaining cancer-free at least one year or more after achievement of a CR (95 percent confidence interval [CI], 72.6-89.8). The majority of adverse reactions were mild and moderate. The most common adverse reactions (≥10 percent) included pollakiuria, dysuria, urinary tract infection, micturition urgency, hematuria, cystitis noninfective, and urinary tract pain. No systemic adverse reactions were reported. The findings were presented during a plenary session at the April 2025 American Urological Association Annual Meeting.1
Despite advancements, there has been little change in the standard of care for patients with HR-NMIBC for over 40 years, and patients have limited treatment options if initial BCG therapy does not work. TAR-200 is the first and only intravesical drug releasing system (iDRS) designed to provide sustained local delivery of a cancer treatment into the bladder. TAR-200 remains in the bladder for three weeks per treatment cycle.1 A healthcare professional places it into the bladder using a co-packaged urinary placement catheter in an outpatient setting in less than five minutes. There is no need for general anesthesia, further monitoring, or other restrictions immediately post-insertion within the healthcare provider's office.
About TAR-200
TAR-200 is an investigational intravesical gemcitabine releasing system. In January 2025, Johnson & Johnson announced the initiation of a new drug application with the FDA for TAR-200 under the Real-Time Oncology Review (RTOR) program. In December 2023, the FDA granted Breakthrough Therapy Designation (BTD) to TAR-200 for the treatment of adult patients with BCG-unresponsive HR-NMIBC with CIS who are ineligible for or have elected not to undergo radical cystectomy. The safety and efficacy of TAR-200 are being evaluated in Phase 2 and Phase 3 studies in patients with NMIBC in SunRISe-1, SunRISe-3 and SunRISe-5 and muscle-invasive bladder cancer (MIBC) in SunRISe-4.
About SunRISe-1, Cohort 2
SunRISe-1 (NCT04640623), Cohort 2, is a single arm, open-label Phase 2b clinical study evaluating the safety and efficacy of TAR-200 monotherapy for BCG-unresponsive HR-NMIBC patients with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for, or elected not to undergo, radical cystectomy. The primary endpoint for Cohort 2 is complete response (CR) rate at any time point, and secondary endpoints include duration of response (DOR), safety, overall survival and quality of life.
About High-Risk Non-Muscle Invasive Bladder Cancer (HR-NMIBC)
High-risk non-muscle invasive bladder cancer (HR-NMIBC) is a type of non-invasive bladder cancer that is more likely to recur or spread beyond the lining of the bladder, called the urothelium, and progress to muscle invasive bladder cancer compared to low-risk NMIBC.2,3 HR-NMIBC is characterized by a high-grade, large tumor size, presence of multiple tumors, and carcinoma in situ (CIS). HR-NMIBC with CIS makes up approximately 10 percent of patients with NMIBC.4 Bacillus Calmette-Guérin (BCG), is an intravesical medication administered directly into the bladder that patients have to hold for a few hours.5,6 BCG is a weakened form of the bacteria found in tuberculosis treatment, and though effective, some patients become unresponsive to it and experience tolerability challenges.7 Radical cystectomy is currently recommended for HR-NMIBC patients who fail BCG therapy; it is a life-altering surgery with a high degree of morbidity and impact on life, and has a post-surgery mortality rate of three to eight percent.8,9 Given that HR-NMIBC typically affects older patients, many may be unwilling or unfit to undergo radical cystectomy.
About Johnson & Johnson
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/ or at www.innovativemedicine.jnj.com. Follow us at @JNJInnovMed. Janssen-Cilag International NV, Janssen Research & Development, LLC, Janssen Biotech, Inc., Janssen Global Services, LLC, Janssen-Cilag, S.A. and Janssen Scientific Affairs, LLC are Johnson & Johnson companies.
Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of TAR-200. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen-Cilag International NV, Janssen Research & Development, LLC, Janssen Biotech, Inc., Janssen Global Services, LLC, Janssen-Cilag, S.A., Janssen Scientific Affairs, LLC and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at http://www.sec.gov, http://www.jnj.com, or on request from Johnson & Johnson. None of Janssen-Cilag International NV, Janssen Research & Development, LLC, Janssen Biotech, Inc., Janssen Global Services, LLC, Janssen-Cilag, S.A., Janssen Scientific Affairs, LLC nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
1 Jacob, J., et al. TAR-200 monotherapy in patients with bacillus Calmette-Guérin–unresponsive high-risk non–muscle-invasive bladder cancer carcinoma in situ: 1-year durability and patient-reported outcomes from SunRISe-1. 2025 American Urological Association Annual Meeting. April 26, 2025.
2 Grab-Heyne K, Henne C, Mariappan P, et al. Intermediate and high-risk non–muscle-invasive bladder cancer: an overview of epidemiology, burden, and unmet needs. Front Oncol. 2023;13:1170124.
3 Lieblich A, Henne C, Mariappan P, Geiges G, Pöhlmann J, Pollock RF. The management of non–muscle-invasive bladder cancer: a comparison of European and
4 Llano A, Chan A, Kuk C, Kassouf W, Zlotta AR. Carcinoma In Situ (CIS): Is There a Difference in Efficacy between Various BCG Strains? A Comprehensive Review of the Literature. Cancers (
5 Jiang S, Redelman-Sidi G. BCG in bladder cancer immunotherapy. Cancers (
6 American Cancer Society. Treating bladder cancer. Accessed June 2025. https://www.cancer.org/cancer/bladder-cancer/treating.html
7 Al Hussein Al Awamlh B, Chang SS. Novel therapies for high-risk non-muscle invasive bladder cancer. Curr Oncol Rep. 25, 83–91 (2023). doi.org/10.1007/s11912-022-01350-9
8 EAU Guidelines. Edn. presented at the EAU Annual Congress Madrid 2025. ISBN 978-94-92671-29-5
9 Marqueen KE, et al. JNCI Cancer Spectr. 2018;2:pky075
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