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While many players headed to the beach for some much-needed rest and relaxation after the grueling season, Linda Noskova opted to go in a different direction with her time off.

The 21-year-old Czech headed to Zanzibar, Tanzania and spent an eye-opening week volunteering at a local school. Noskova experienced what life is like for the 300 students firsthand, living in a volunteer house with shared rooms and no air conditioning.

The trip offered a great deal of perspective, and it was one of the most rewarding experiences of Noskova’s life.

“Traveling to Zanzibar, Africa to volunteer was one of the most meaningful experiences of my life, and finally making that long-time dream happen felt both surreal and unforgettable,” the World No. 13 said. “I prepared myself for the cultural shock, but nothing could compare to being there in person — seeing how people live, understanding their challenges and feeling their warmth despite having so little.”

Noskova was touched and inspired by how kind and appreciative the students were, and is determined to continue providing opportunities for the community.

“Their kindness, their excitement and their resilience changed something in me,” Noskova said, “and supporting them now feels like the most natural thing to do. This trip opened my eyes in ways I didn’t expect, and it reminded me how fortunate we are — an experience I believe everyone should have at least once in their life.”

Noskova’s volunteer work comes on the heels of the season of her career. She made her debut in the Top 20 in October following her run to the final of the WTA 1000 event in Beijing, where she lost to Amanda Anisimova in three sets. Earlier in the year she made the final in Prague, and reached another final in her last tournament of the year, in Tokyo.

A bone regeneration device using bioactive materials pioneered by Querrey Simpson Institute for Regenerative Engineering at Northwestern University (QSI RENU) director Guillermo Ameer was recently used in its first surgical case, Acuitive Technologies Inc. announced. 

Called Citregraft, the technology is composed of the citrate-based polymers developed in the Ameer laboratory as well as bioactive glass. It is a highly porous, synthetic bone graft substitute that can be morselized to fit irregular defects. After placement in a bony void, Citregraft binds local growth factors and steadily releases citrate to support bone regeneration before resorbing and being replaced by the patient’s natural bone.

In its first surgical use, the sponge-like material repaired bone tissue that was harvested as part of an ACL reconstruction on the knee. The device received FDA clearance last November and is one of several products in Acuitive Technologies’ CITREGEN product line.

“Twenty years after the first report of citrate-based polymers we now see another major milestone: the use of our biomaterial technology to develop a citrate-based bioactive scaffold to regenerate bone tissue in patients,” said Ameer, the Daniel Hale Williams Professor of Biomedical Engineering at Northwestern Engineering and a professor of surgery in Northwestern’s Feinberg School of Medicine. “This builds on the success and expands the impact our biomaterial technology and collaboration with Acuitive Technologies has made on medical devices that regenerate musculoskeletal tissues.

“I am very proud of our research team members, past and present, who have contributed to the development and applications of citrate-based biomaterials. I am humbled to see that the impact of our publications goes beyond academic research, being validated by industry, and now improving the lives of patients.”

Editor’s note: Intellectual property associated with the Citregraft is subject to an exclusive license between Northwestern and Vesseltek Biomedical. Pursuant to the terms of that license, Northwestern has financial interest in Vesseltek Biomedical. Vesseltek Biomedical sublicenses Northwestern intellectual property associated with Citregraft to Acuitive Technologies. Ameer has financial interest in Vesseltek Biomedical and serves on the scientific advisory board of Acuitive Technologies.

New data from Cohort 4 of the SunRISe-1 study show more than 95 percent of patients remained progression free at one year, with more than 92 percent not undergoing bladder removal

Patients with this type of bladder cancer have limited choices beyond radical cystectomy, highlighting the need for newer therapies for bladder preservation

RARITAN, N.J., Dec. 5, 2025 /PRNewswire/ — Johnson & Johnson (NYSE:JNJ) announced today that new data from the investigational Cohort 4 of the Phase 2b SunRISe-1 study show treatment with gemcitabine intravesical system resulted in high one-year disease-free survival (DFS), progression-free survival (PFS), and overall survival (OS) rates in patients with Bacillus Calmette-Guérin (BCG)-unresponsive, high-risk, papillary-only non-muscle invasive bladder cancer (NMIBC).¹ These data were featured as a late-breaking oral presentation at the Society of Urologic Oncology (SUO) 2025 Annual Meeting and build upon data presented at the 2025 American Urological Association (AUA) Annual Meeting.

“The findings are meaningful, as the majority of patients remained free of cancer recurrence at one year despite having papillary tumors that carry a high risk for recurrence and a significant risk of progression to a more aggressive, muscle-invasive stage of disease,” said Siamak Daneshmand*, M.D., Professor of Urology, University of Southern California, and presenting author. “Bladder removal has traditionally been the primary path forward for these patients, a life-altering procedure that can have a significant impact on a patient’s quality of life.”

“At Johnson & Johnson, we are committed to developing innovative treatments for patients with high-risk NMIBC who have few options beyond life-altering surgery,” said Christopher Cutie, M.D., Vice President, Disease Area Leader, Bladder Cancer, Johnson & Johnson Innovative Medicine. “Those with papillary-only disease face particularly difficult decisions, as surgical removal of the bladder has long been the standard of care for patients who are unresponsive or resistant to BCG.”

Cohort 4 of the Phase 2b SunRISe-1 study focused on 52 patients with papillary-only, high-risk NMIBC whose disease did not respond or stopped responding to BCG therapy and who were ineligible for or declined radical cystectomy. The therapy was administered every three weeks for six months, followed by every 12 weeks for up to an additional 18 months, to evaluate its potential to prevent the recurrence or progression of high-grade papillary tumors.¹ The results support continued evaluation in the ongoing Phase 3 SunRISe-5 study (NCT06211764) comparing gemcitabine intravesical system to chemotherapy in patients with previously BCG-treated, papillary-only NMIBC.

At median follow-up of 15.9 months (range, 4-20 months), the one-year DFS rate was 74.3 percent (95 percent confidence interval [CI], 59.2-84.6), meaning nearly three out of four patients remained free from cancer recurrence. Results were similar across patients with high-grade Ta and T1 papillary tumors, 74.8 percent and 74.1 percent, respectively (95 percent CI, 54.3-87.1 and 48.5-88.3). At one year, PFS was 95.6 percent (95 percent CI, 83.5-98.9) and OS was 98 percent (95 percent CI, 86.6-99.7). Notably, 92.3 percent of patients did not undergo radical cystectomy, and median time to cystectomy was not reached. Overall Health Status and Physical Functioning scores were maintained during treatment with gemcitabine intravesical system.¹ 

The therapy was generally well-tolerated. Most patients (80.8 percent) experienced treatment-related side effects that were low grade, such as mild urinary symptoms, including burning, frequency, or urgency. More serious side effects (13.5 percent) were uncommon and most often involved bladder pain. A small number of patients (7.7 percent) discontinued treatment due to side effects, and no treatment-related deaths were reported.¹

About SunRISe-1, Cohort 4

SunRISe-1 (NCT04640623) is an ongoing Phase 2b, open-label, multicenter study evaluating the efficacy and safety of gemcitabine intravesical system in patients with BCG-unresponsive HR-NMIBC who are ineligible for, or elected not to undergo, radical cystectomy. Cohort 4 specifically enrolls patients with papillary-only disease. The primary endpoint of Cohort 4 is disease-free survival (DFS) rate at 12 months. Key secondary endpoints included safety and tolerability.²

About High-Risk Non-Muscle Invasive Bladder Cancer

High-risk non-muscle invasive bladder cancer 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.^3,4 HR-NMIBC makes up 15-44 percent of patients with NMIBC and is characterized by a high-grade, large tumor size, presence of multiple tumors, and carcinoma in situ.⁵ Radical cystectomy is currently recommended for HR-NMIBC patients who fail BCG therapy, with over 90 percent cancer-specific survival if performed before muscle-invasive progression.^6,7 Given that NMIBC typically affects older patients, many may be unwilling or unfit to undergo radical cystectomy.⁸ The high rates of recurrence and progression can pose significant morbidity and distress for these patients.^3,4

About INLEXZO™ (gemcitabine intravesical system)

INLEXZO™ is approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors.

The safety and efficacy of INLEXZO™ is being evaluated in clinical trials in patients with MIBC in SunRISe-4, and HR-NMIBC in SunRISe-1, SunRISe-3, and SunRISe-5. 

The legal manufacturer for INLEXZO™ is Janssen Biotech, Inc. 

INLEXZO™ IMPORTANT SAFETY INFORMATION⁹

CONTRAINDICATIONS 

INLEXZO™ is contraindicated in patients with: 

• Perforation of the bladder. 
• Prior hypersensitivity reactions to gemcitabine or any component of the product. 

WARNINGS AND PRECAUTIONS 

Risks in Patients with Perforated Bladder 

INLEXZO™ may lead to systemic exposure to gemcitabine and to severe adverse reactions if administered to patients with a perforated bladder or to those in whom the integrity of the bladder mucosa has been compromised. 

Evaluate the bladder before the intravesical administration of INLEXZO™ and do not administer to patients with a perforated bladder or mucosal compromise until bladder integrity has been restored. 

Risk of Metastatic Bladder Cancer with Delayed Cystectomy 

Delaying cystectomy in patients with BCG-unresponsive CIS could lead to development of muscle invasive or metastatic bladder cancer, which can be lethal. The risk of developing muscle invasive or metastatic bladder cancer increases the longer cystectomy is delayed in the presence of persisting CIS. 

Of the 83 evaluable patients with BCG-unresponsive CIS treated with INLEXZO™ in Cohort 2 of SunRISe-1, 7 patients (8%) progressed to muscle invasive (T2 or greater) bladder cancer. Three patients (3.5%) had progression determined at the time of cystectomy. The median time between determination of persistent or recurrent CIS or T1 and progression to muscle invasive disease was 94 days. 

Magnetic Resonance Imaging (MRI) Safety 

INLEXZO™ can only be safely scanned with MRI under certain conditions. Refer to section 5.3 of the USPI for details on conditions. 

Embryo-Fetal Toxicity 

Based on animal data and its mechanism of action, INLEXZO™ can cause fetal harm when administered to a pregnant woman if systemic exposure occurs. In animal reproduction studies, systemic administration of gemcitabine was teratogenic, embryotoxic, and fetotoxic in mice and rabbits. 

Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for 6 months after final removal of INLEXZO™. Advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 3 months after final removal of INLEXZO™. 

ADVERSE REACTIONS 

Serious adverse reactions occurred in 24% of patients receiving INLEXZO™. Serious adverse reactions that occurred in >2% of patients included urinary tract infection, hematuria, pneumonia, and urinary tract pain. Fatal adverse reactions occurred in 1.2% of patients who received INLEXZO™, including cognitive disorder. 

The most common (>15%) adverse reactions, including laboratory abnormalities, were urinary frequency, urinary tract infection, dysuria, micturition urgency, decreased hemoglobin, increased lipase, urinary tract pain, decreased lymphocytes, hematuria, increased creatinine, increased potassium, increased AST, decreased sodium, bladder irritation, and increased ALT. 

USE IN SPECIFIC POPULATIONS 

Pregnancy 

There are no available data on the use of INLEXZO™ in pregnant women to inform a drug-associated risk. Please see Embryo-Fetal Toxicity for risk information related to pregnancy. 

Lactation 

Because of the potential for serious adverse reactions in breastfed infants, advise women not to breastfeed during treatment and for 1 week after final removal of INLEXZO™. 

Females and Males of Reproductive Potential 

Pregnancy Testing – Verify pregnancy status in females of reproductive potential prior to initiating INLEXZO™. 

Contraception – Please see Embryo-Fetal Toxicity for information regarding contraception. 

Infertility (Males) – Based on animal studies, INLEXZO™ may impair fertility in males of reproductive potential. It is not known whether these effects on fertility are reversible. 

Geriatric Use 

Of the patients given INLEXZO™ monotherapy in Cohort 2 of SunRISe-1, 72% were 65 years of age or older and 34% were 75 years or older. There were insufficient numbers of patients <65 years of age to determine if these patients respond differently to patients 65 years of age and older. 

Please read full Prescribing Information and Instructions for Use for INLEXZO™. 

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.

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 INLEXZO™. 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 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. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.  

*Dr. Siamak Daneshmand has provided consulting, advisory, and speaking services to Johnson & Johnson; he has not been paid for any media work.

¹ Daneshmand, S., & colleagues. (2025). Gemcitabine intravesical system (TAR-200) monotherapy in patients with Bacillus Calmette-Guérin–unresponsive papillary disease–only high-risk non–muscle-invasive bladder cancer: 1-year disease-free survival results from SUNRISE-1. Abstract presented at the Society of Urologic Oncology (SUO) Annual Meeting.
² ClinicalTrials.gov. A Study of TAR-200 in Combination With Cetrelimab, TAR-200 Alone, or Cetrelimab Alone in Participants With Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Intravesical Bacillus Calmette-Guérin Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy (SunRISe-1). https://clinicaltrials.gov/study/NCT04640623. Accessed December 2025.
³ 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.
⁴ 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 UK guidelines. J Clin Urol. 2018;11(2):144-148.
⁵ Babjuk M, Burger M, Capoun O, et al. European Association of Urology Guidelines on Non-muscle-invasive Bladder Cancer (Ta, T1, and Carcinoma in Situ). Eur Urol. 2022;81(1):75-94. doi:10.1016/j.eururo.2021.08.010
⁶ Brooks NA, O’Donnell MA. Treatment options in non–muscle-invasive bladder cancer after BCG failure. Indian J Urol. 2015;31(4):312-319. doi:10.4103/0970-1591.166475
⁷ Guancial EA, Roussel B, Bergsma DP, et al. Bladder cancer in the elderly patient: challenges and solutions. Clin Interv Aging. 2015;10:939-949.
⁸ Chamie K, Litwin MS, Bassett JC, et al. Recurrence of high-risk bladder cancer: A population-based analysis. Cancer. 2013;119(17):3219-3227.
⁹ INLEXZO™ U.S. Prescribing Information.

SOURCE Johnson & Johnson