Can a pretzel-shaped device rewrite the story of bladder cancer?

In September 2025, the U.S. Food and Drug Administration (FDA) approved Inlexzo™ (formerly TAR-200), a novel intravesical gemcitabine delivery system developed by Johnson & Johnson for adult patients with BCG-unresponsive, non–muscle-invasive bladder cancer (NMIBC) with carcinoma in situ, with or without papillary tumors.

This marks a turning point: a device-based therapy moving from clinical promise to a real-world option for patients who previously had limited choices.

TAR-200’s journey—from engineering innovation, through trial validation, to FDA approval—offers lessons in how next-generation therapies can shift paradigms in cancer care. A larger, ongoing SUNRISE-5 Phase 3 trial is now evaluating TAR-200 in a broader patient population, helping to further define its long-term safety and efficacy.

The Technology: How TAR-200 Works

TAR-200 is a pretzel-shaped intravesical device designed to remain within the bladder and deliver gemcitabine locally over extended periods. By releasing the drug directly where it’s needed, exposure to the rest of the body is minimized—lower systemic toxicity, higher local concentration.

Key features:

• A single insertion via catheter in an outpatient setting, typically without general anesthesia.
  
• The device remains indwelling for treatment cycles lasting 3 weeks per cycle, for up to 14 cycles.
  
• After the intensive phase (every 3 weeks for 6 months), dosing transitions to maintenance schedules every 12 weeks, continuing up to 18 months or until recurrence.

By maintaining sustained drug concentration at the bladder wall, TAR-200 overcomes limitations of standard intravesical instillations, which have short dwell times.

With its unique pretzel-shaped design, TAR-200 delivers chemotherapy directly to the tumor site, redefining what’s possible in bladder-sparing treatment.

Clinical Evidence: Trials & Results

SUNRISE-1 (Phase 2b)

The pivotal evidence supporting TAR-200’s FDA approval comes from Cohort 2 of SUNRISE-1, where monotherapy with TAR-200 (Inlexzo) was tested in BCG-unresponsive NMIBC with CIS.

• Among 83 evaluable patients, the complete response (CR) rate was 82% (95% CI: 72–90).
  
• At 12 months, 51% of responders remained in CR.
  
• Safety outcomes were favorable: insertion success rates were high, and most adverse events were manageable urinary symptoms.

Dr. Sia Daneshmand, Professor of Urology at Keck Medicine of USC, noted:

“This is the most effective therapy reported to date for the most common form of bladder cancer.”

Phase 3 Trials: SUNRISE-3 and SUNRISE-5

SUNRISE-3

This Phase 3 trial explores TAR-200 (or TAR-200 plus cetrelimab) as a first-line alternative to BCG in BCG-naïve high-risk NMIBC patients, comparing efficacy, safety, and long-term outcomes relative to BCG.

SUNRISE-5

This Phase 3 study is designed for patients who relapse after BCG therapy, comparing TAR-200 to standard intravesical chemotherapy to validate its role as a second-line therapy.

These ongoing trials will provide the randomized, multicenter evidence necessary to cement TAR-200’s place in clinical guidelines.

As we shared in our LinkedIn update, the progression of these trials is critical to understanding TAR-200’s full potential in both first- and second-line treatment settings.

Clinical Leadership: Dr. Sia Daneshmand

Dr. Daneshmand has led the clinical development of TAR-200 from concept to approval, overseeing the design and execution of the SUNRISE trials and the publication of efficacy data.

Under his guidance, the protocol and tolerability of TAR-200 were rigorously assessed, with near 99% insertion success in SUNRISE-1 and manageable adverse events. His leadership adds credibility and context to how TAR-200 moved from early concept to FDA-approved therapy.

Comparing TAR-200 with Current Standard of Care

BCG Therapy

• Bacillus Calmette-Guérin (BCG) is the long-standing standard for intermediate and high-risk NMIBC.
  
• Many patients are unresponsive or relapse after BCG (failure rates up to ~40%).
  
• Historically, options for BCG-unresponsive patients were limited to radical cystectomy (bladder removal), which carries significant morbidity and quality-of-life implications.

How TAR-200 Might Shift Practice

• Provides a bladder-sparing treatment option for patients who otherwise face surgery.
  
• Maintains local drug delivery, potentially reducing systemic exposure and improving tolerability relative to systemic chemotherapy.
  
• With FDA approval, TAR-200 (Inlexzo) becomes a new standard-of-care candidate for BCG-unresponsive NMIBC.

What FDA Approval Means & Next Steps

The FDA’s approval of Inlexzo™ is significant:

• First intravesical drug-releasing system (iDRS) approved for extended local chemotherapy delivery in the bladder.
  
• Signals confidence in SUNRISE-1 data and paves the way for broader adoption.
  
• SUNRISE-3 and SUNRISE-5 will define its role in earlier- and later-line settings.

For TrialX, FDA approval underscores our mission: bridging innovation and clinical trial access, giving patients visibility into ongoing trials (like SUNRISE-3 and SUNRISE-5) where they may be eligible.

Connecting Patients and Trials

Through tools such as TrialX’s Clinical Trial Finder, patients, caregivers, and clinicians can easily locate and follow studies like SUNRISE-3 and SUNRISE-5, improving visibility into recruitment and enrollment opportunities.

By highlighting emerging innovations like TAR-200/Inlexzo, TrialX contributes to increasing awareness of how clinical research translates into real-world patient impact—bridging discovery and access.

TAR-200’s path from breakthrough to FDA-approved therapy is a case study in how device-based drug delivery can reshape cancer care. With sustained release, bladder preservation, and strong clinical data, Inlexzo opens a new chapter for BCG-unresponsive NMIBC patients.

SUNRISE-3 and SUNRISE-5 will define its broad usage. For patients, clinicians, and researchers, the future demands not just innovation—but access, data, and momentum.

Looking for ways to participate in cutting-edge cancer research? Discover and track relevant clinical trials using our platform.