Inlexzo FDA Approval History
Last updated by Melisa Puckey, BPharm on Sep 9, 2025.
FDA Approved: Yes (First approved September 9, 2025)
Brand name: Inlexzo
Generic name: gemcitabine
Dosage form: intravesical system
Previous Name: TAR-200
Company: Johnson & Johnson
Treatment for: Bladder Cancer
Inlexzo (gemcitabine intravesical system) is a treatment for certain patients with BCG-unresponsive non-muscle invasive bladder cancer
- Inlexzo (gemcitabine intravesical system) is a treatment for adult patients with Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors.
-
Non-muscle invasive bladder cancer (NMIBC) is a type of non-invasive bladder cancer that can be classified as low, intermediate, or high risk depending on the presence of characteristics including tumor size, presence of multiple tumors, and carcinoma in situ (CIS). Some patients become unresponsive to Bacillus Calmette-Guérin (BCG), which is the current standard of care, and may be unwilling or unable to undergo radical cystectomy.
- Inlexzo is designed for patients wishing to preserve their bladder and is the first and only intravesical drug-releasing system (iDRS) to provide extended local delivery of a cancer medication into the bladder.
-
Inlexzo is administered into the bladder once every 3 weeks up to 6 months (8 doses), followed by once every 12 weeks (6 doses). Inlexzo is placed into the bladder using the co-packaged urinary catheter and stylet. This process takes a few minutes in the healthcare provider's office without general anesthesia.
- Inlexzo should not be used if there is a tear or hole (perforation) in the bladder or a history of allergic reaction to gemcitabine or any of the ingredients in this medicine.
- Adverse reactions were urinary frequency, urinary tract infection, dysuria, micturition urgency, urinary tract pain, hematuria, bladder irritation. Inlexzo also caused including laboratory abnormalities including decreased hemoglobin, increased lipase, decreased lymphocytes, increased creatinine, increased potassium, increased aspartate aminotransferase (AST), decreased sodium, and increased alanine transaminase (ALT)
- Warnings and precautions
- Risks in Patients with Perforated Bladder: Evaluate the bladder before the intravesical insertion of INLEXZO. Do not administer to patients with a perforated bladder or in whom the integrity of the bladder mucosa has been compromised. (
- Risk of Metastatic Bladder Cancer with Delayed Cystectomy: Delaying cystectomy can lead to the development of metastatic bladder cancer, which can be lethal.
- Magnetic Resonance Imaging (MRI) Safety: INLEXZO can only be safely scanned with MRI under certain conditions.
- Embryo-Fetal Toxicity: Can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception.
Development timeline for Inlexzo
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.