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Association details:
| Biomarker: | No biomarker |
|---|---|
| Cancer: | Bladder Cancer |
| Drug: | GemRIS (gemcitabine-releasing intravesical system) (DNA synthesis inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Johnson & Johnson’s Investigational TAR-200 Granted U.S. FDA Breakthrough Therapy Designation for the Treatment of High-Risk Non-Muscle-Invasive Bladder Cancer
Published date:
12/04/2023
Excerpt:
Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has granted TAR-200 Breakthrough Therapy Designation (BTD) for the potential future treatment of patients with Bacillus Calmette Guérin (BCG)-unresponsive high-risk non-muscle-invasive bladder cancer (HR-NMIBC), who are ineligible for or elected not to undergo radical cystectomy (surgical removal of the bladder).
