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Association details:
| Biomarker: | HLA-G positive |
|---|---|
| Cancer: | Renal Cell Carcinoma |
| Drug: | IVS-3001 (HLA G-targeted CAR-T immunotherapy) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
FDA Grants Fast Track designation to IVS-3001, a CAR-T Cell Therapy in the Treatment of Renal Cell Carcinoma
Published date:
07/31/2023
Excerpt:
Invectys...is pleased to announce the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its revolutionary product, IVS-3001….The Fast Track designation to IVS-3001 was based on the compelling data from the Investigational New Drug Application (IND) submission, and the potential for addressing the unmet need in patients with HLA-G positive locally advanced or metastatic clear cell renal cell carcinoma (RCC) who have failed or are intolerant to standard RCC therapies.