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Association details:
| Biomarker: | No biomarker |
|---|---|
| Cancer: | Bladder Cancer |
| Drug: | cretostimogene grenadenorepvec (CG0070) (GM-CSF agonist, Cell death stimulant) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
CG Oncology Receives Both FDA Fast Track and Breakthrough Therapy Designation for Cretostimogene Grenadenorepvec in High-Risk BCG-Unresponsive Non-Muscle Invasive Bladder Cancer
Published date:
12/05/2023
Excerpt:
CG Oncology, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted both Fast Track Designation and Breakthrough Therapy Designation for cretostimogene grenadenorepvec in high-risk Bacillus Calmette-Guérin (BCG)-unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC) with carcinoma in situ with or without Ta or T1 (papillary) tumors.
