FDA

Intravesical therapy approved for early bladder cancer

September 12, 2025

Brand name: Inlexzo

Generic name: gemcitabine intravesical system

Manufacturer: Janssen Biotech

Approval date: September 9, 2025

FDA approved Inlexzo (gemcitabine intravesical system) for adults with Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. Gemcitabine intravesical system is co-packaged with a urinary catheter and stylet used for insertion through a urinary catheter into the bladder.

Efficacy

Efficacy was evaluated in Cohort 2 of SunRISe-1 (NCT04640623), a single-arm, multi-center trial enrolling 83 patients with BCG-unresponsive NMIBC with CIS with or without papillary tumors following transurethral resection. Patients received the gemcitabine intravesical system every 3 weeks for 6 months, followed by once every 12 weeks for up to 18 months.

Tumor status was assessed with cystoscopy and urine cytology every 12 weeks during the initial two years of treatment, after which cystoscopy was performed at least every 24 weeks. Mandatory biopsies were performed at 24 and 48 weeks after treatment initiation.

The major efficacy outcome measures were complete response (CR) at any time (defined as negative results for cystoscopy [with TURBT/biopsies as applicable] and urine cytology) and duration of response (DOR). CR assessment at each timepoint was based on central pathology review.

CR rate was 82% (95% confidence interval, 72-90) and 51% of patients with a CR had a DOR ≥12 months.

Safety

The most common adverse reactions reported were urinary frequency, UTI, dysuria, urinary urgency, decreased hemoglobin, increased lipase, urinary tract pain, decreased lymphocytes, hematuria, increased creatinine, increased potassium, increased ALT and AST, decreased sodium, and bladder irritation.

The prescribing information includes warnings and precautions describing risks of administering gemcitabine intravesical system in patients with a perforated bladder, risk of metastatic bladder cancer with delayed cystectomy, MRI safety, and embryo-fetal toxicity.

Recommended dose

Inlexzo delivers 225 mg of gemcitabine into the bladder, with an indwelling period following each insertion of 3 weeks prior to removal. The intravesical system is inserted once every 3 weeks for up to 6 months (8 doses), followed by once every 12 weeks for up to 18 months (6 doses), or until persistent or recurrent high-grade NMIBC, disease progression, or unacceptable toxicity.

Sources:

FDA approves gemcitabine intravesical system for non-muscle invasive bladder cancer [News release]. 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-gemcitabine-intravesical-system-non-muscle-invasive-bladder-cancer

Inlexzo (gemcitabine intravesial system) [package insert]. Food and Drug Administration. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219683s000lbl.pdf Revised September 2025. Accessed September 11, 2025.

US FDA approval of Inlexzo™ (gemcitabine intravesical system) set to transform how certain bladder cancers are treated [News release]. 2025. https://www.jnj.com/media-center/press-releases/u-s-fda-approval-of-inlexzo-gemcitabine-intravesical-system-set-to-transform-how-certain-bladder-cancers-are-treated