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Association details:
| Biomarker: | No biomarker |
|---|---|
| Cancer: | B Acute Lymphoblastic Leukemia |
| Drug: | Aucatzyl (obecabtagene autoleucel) (CD19-targeted CAR-T immunotherapy) |
| Direction: | Sensitive |
Evidence:
Source:
Published date:
11/08/2024
Excerpt:
On November 8, 2024, the Food and Drug Administration approved obecabtagene autoleucel (Aucatzyl, Autolus Inc.), a CD19-directed genetically modified autologous T cell immunotherapy, for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
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).
