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Association details:
| Biomarker: | No biomarker |
|---|---|
| Cancer: | B Acute Lymphoblastic Leukemia |
| Drug: | obecabtagene autoleucel (AUTO1) (CD19-targeted CAR-T immunotherapy) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
FDA Grants Regenerative Medicine Advanced Therapy (RMAT) designation to Autolus’ CAR T cell therapy, obe-cel, for the treatment of adult B-ALL
Published date:
04/25/2022
Excerpt:
Autolus Therapeutics plc (Nasdaq: AUTL)...today announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to its lead gene therapy obecabatagene autoleucel (obe-cel), a CD19-directed autologous chimeric antigen receptor (CAR) T therapy that is being investigated in the ongoing FELIX Phase 2 study of adult relapsed / refractory B-Acute Lymphocytic Leukemia (ALL).
