Key Highlights:
- First and only intravesical drug-releasing system approved by FDA for BCG-unresponsive bladder cancer.
- 82% complete response rate in clinical trials, with 51% maintaining response beyond one year.
- Positioned as a bladder-preserving alternative to radical cystectomy for high-risk patients.
A Breakthrough in Bladder Cancer Treatment
The U.S. FDA has approved INLEXZO™ (gemcitabine intravesical system), marking the first innovative therapy in decades for patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). This approval offers a potential practice-changing alternative to radical cystectomy, a life-altering surgery often required after BCG treatment failure.
Clinical Success with Strong Durability
Data from the Phase 2b SunRISe-1 study demonstrated that 82% of patients achieved a complete response following INLEXZO™ treatment, with over half maintaining their response for at least one year. These results represent a significant advancement in bladder cancer care, giving patients and physicians new hope for long-term disease management.
Ease of Use and Patient Accessibility
INLEXZO™ is placed in an outpatient setting within minutes using a specialized catheter system and remains in the bladder for three weeks per cycle. The system eliminates the need for general anesthesia and prolonged monitoring, enabling patients to undergo treatment without major disruption to daily life. Johnson & Johnson is supporting access through its J&J withMe program, which provides cost support, care navigation, and educational resources.
Industry Impact and Future Potential
With FDA designations including Breakthrough Therapy and Priority Review, INLEXZO™ highlights Johnson & Johnson’s leadership in oncology innovation. Its approval is expected to reshape standards of care for BCG-unresponsive NMIBC, while additional trials in the SunRISe program continue to explore its potential across broader bladder cancer populations.
About Johnson & Johnson
Johnson & Johnson (NYSE: JNJ) is a global healthcare leader advancing innovative medicine and medical technologies. With a strong focus on oncology, immunology, neuroscience, and surgery, J&J delivers breakthrough therapies that improve and extend lives worldwide. Learn more at J&J Innovative Medicine.
About INLEXZO™
INLEXZO™ (gemcitabine intravesical system) is the first FDA-approved intravesical drug-releasing system designed for extended local delivery of chemotherapy into the bladder. It is indicated for adults with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors. INLEXZO™ offers a bladder-preserving treatment option, addressing a critical unmet need in urologic oncology.
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