The FDA approved INLEXZO™ / gemcitabine intravesical on September 9, 2025, to treat BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS). This innovative therapy, known as INLEXZO gemcitabine intravesical, offers oncologists and patients a new way to manage this tough condition. For example, it helps those seeking to avoid surgery.
What is INLEXZO™ / Gemcitabine Intravesical?
INLEXZO™ / gemcitabine intravesical delivers 225 mg of gemcitabine to the bladder. A doctor inserts it using a catheter and stylet in a quick outpatient visit, needing no anesthesia. The treatment plan includes ensuring that INLEXZO gemcitabine intravesical is easily administered and effective.
- Initial phase: Insert every 3 weeks for 6 months (8 doses).
- Maintenance phase: Insert every 12 weeks for up to 18 months (6 doses).
- Indwelling period: Each dose stays in the bladder for 3 weeks.
Thus, INLEXZO™ / gemcitabine intravesical suits patients who want to avoid radical cystectomy, a surgery with a 3–8% mortality risk. Learn more about bladder cancer treatments on OncologyTube’s Bladder Cancer Hub.
SunRISe-1 Trial: INLEXZO™ / Gemcitabine Intravesical Efficacy
The SunRISe-1 trial (NCT04640623) tested INLEXZO™ / gemcitabine intravesical in 83 patients with BCG-unresponsive NMIBC with CIS. Results show that the efficacy of INLEXZO gemcitabine in an intravesical format is promising:
- Complete Response (CR) Rate: 82% had no cancer signs after treatment (95% CI: 72, 90).
- Duration of Response (DOR): 51% of responders kept their response for at least 12 months.
Doctors used cystoscopy and urine tests every 12 weeks for two years, with biopsies at 24 and 48 weeks. Therefore, INLEXZO™ / gemcitabine intravesical offers hope for patients with few options. Read the full study details at ClinicalTrials.gov.
Alt: SunRISe-1 trial results for INLEXZO gemcitabine intravesical
Safety Profile of INLEXZO™ / Gemcitabine Intravesical
INLEXZO™ / gemcitabine intravesical works well for most, but risks exist. Common side effects (≥15%) include:
- Frequent urination
- Urinary tract infection (UTI)
- Painful urination (dysuria)
- Urgent need to urinate
- Blood in urine (hematuria)
- Bladder irritation
Serious risks include:
- Bladder perforation: Avoid in patients with a damaged bladder.
- Delayed cystectomy: Waiting may worsen cancer. In the trial, 8% of patients developed muscle-invasive cancer within 94 days on average.
- Embryo-fetal toxicity: Pregnant women must avoid it. Women need contraception for 6 months after treatment, men for 3 months.
- MRI safety: Follow specific MRI rules.
Serious side effects hit 24% of patients, with 1.2% facing fatal issues, like confusion. Check full details at Drugs@FDA and report problems to FDA’s MedWatch at 1-800-FDA-1088.
Why INLEXZO™ / Gemcitabine Intravesical Matters
For oncologists, INLEXZO™ / gemcitabine intravesical changes NMIBC care, especially for BCG-unresponsive cases, in which INLEXZO gemcitabine in an intravesical delivery format shows great promise. Since 72% of trial patients were over 65, it fits older patients well. Plus, its outpatient delivery simplifies treatment. Explore more oncology innovations at OncologyTube’s Treatment Advances.
For patients, it avoids major surgery. Dr. Sia Daneshmand, SunRISe-1 principal investigator, says, “In my experience, INLEXZO is well-tolerated and delivers clinically meaningful results. This will change the way we treat appropriate patients that haven’t responded to traditional therapy.” As a result, it brings hope to those with limited choices.
Johnson & Johnson’s J&J withMe program offers free support, like cost help and education. Visit INLEXZO.com for details.
FDA’s Fast-Track Approval
The FDA used Priority Review, Breakthrough Therapy Designation, and Real-Time Oncology Review (RTOR) to approve INLEXZO™ / gemcitabine intravesical quickly, ensuring speedy access for patients needing INLEXZO gemcitabine intravesical. These steps sped up access for NMIBC patients. Learn about FDA processes at FDA Oncology.
Advancing Bladder Cancer Care
Meri-Margaret Deoudes, CEO of the Bladder Cancer Advocacy Network, says, “Patients need options like INLEXZO to navigate bladder-sparing treatments confidently.” Indeed, INLEXZO™ / gemcitabine intravesical helps the 10% of NMIBC patients with CIS who fail BCG therapy.