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Association details:
| Biomarker: | No biomarker |
|---|---|
| Cancer: | Diffuse Large B Cell Lymphoma |
| Drug: | IMPT-314 (CD19-targeted CAR-T immunotherapy, CD20-targeted CAR-T immunotherapy) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
ImmPACT Bio Granted FDA Fast Track Designation for IMPT-314 in Patients with Relapsed or Refractory Aggressive B-cell Lymphoma
Published date:
05/15/2023
Excerpt:
ImmPACT Bio USA, Inc...announced the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) for IMPT-314, a potential first-in-class CD19/CD20 CAR T therapy for the treatment of patients with B-cell mediated malignancies. These include relapsed or refractory (R/R) aggressive B-cell lymphoma, diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), high grade B cell lymphoma (HGBCL), primary mediastinal B-cell lymphoma (PMBCL), and DLBCL arising from follicular lymphoma (FL), after two or more lines of systemic therapy.
