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FDA approves gemcitabine intravesical system for non-muscle invasive bladder cancer
What's New: Drugs RSS Feed · By FDA ·
The Brief
- On September 9, 2025, the FDA approved the gemcitabine intravesical system, marketed as Inlexzo by Janssen Biotech, Inc.
- The approval covers adults with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS).
Why it matters
It adds a drug-delivery treatment option, given directly into the bladder, for patients whose NMIBC with CIS no longer responds to BCG therapy.
Who’s affected
- Adults with BCG-unresponsive NMIBC with carcinoma in situ
- #bladder cancer
- #fda approval
- #drug approval
- #oncology
- #intravesical therapy
On September 9, 2025, the Food and Drug Administration approved gemcitabine intravesical system (Inlexzo, Janssen Biotech, Inc.) for adults with Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without…
Timeline
FDA approves gemcitabine intravesical system (Inlexzo) for BCG-unresponsive NMIBC with CIS
What's New: Drugs RSS Feed
FDA approves gemcitabine intravesical system for non-muscle invasive bladder cancer