FDA Oncology Announcements

Anti-CD19 CAR T-cell × Clear all

14 Announcements

FDA approves lisocabtagene maraleucel for relapsed or refractory marginal zone lymphoma

Trial: TRANSCEND FL
Drug: Breyanzi (lisocabtagene maraleucel) · Anti-CD19 CAR T-cell
Condition: Lymphoid

FDA approves obecabtagene autoleucel for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia

Drug: Aucatzyl (obecabtagene autoleucel) · Anti-CD19 CAR T-cell
Conditions: LymphoidOther hematologic neoplasm

FDA approves lisocabtagene maraleucel for relapsed or refractory mantle cell lymphoma

Drug: Breyanzi (lisocabtagene maraleucel) · Anti-CD19 CAR T-cell
Condition: Lymphoid

FDA grants accelerated approval to lisocabtagene maraleucel for follicular lymphoma

Drug: Breyanzi (lisocabtagene maraleucel) · Anti-CD19 CAR T-cell
Condition: Lymphoid

FDA approves lisocabtagene maraleucel for second-line treatment of large B-cell lymphoma

Trial: TRANSFORM
Drug: Breyanzi (lisocabtagene maraleucel) · Anti-CD19 CAR T-cell
Condition: Lymphoid

FDA approves tisagenlecleucel for relapsed or refractory follicular lymphoma

Trial: ELARA
Drug: Kymriah (tisagenlecleucel) · Anti-CD19 CAR T-cell
Condition: Lymphoid

FDA approves axicabtagene ciloleucel for second-line treatment of large B-cell lymphoma

Drug: Yescarta (axicabtagene ciloleucel) · Anti-CD19 CAR T-cell
Condition: Lymphoid

FDA approves brexucabtagene autoleucel for relapsed or refractory B-cell precursor acute lymphoblastic leukemia

Trial: ZUMA-3
Drug: Tecartus (brexucabtagene autoleucel) · Anti-CD19 CAR T-cell
Conditions: LymphoidOther hematologic neoplasm

FDA grants accelerated approval to axicabtagene ciloleucel for relapsed or refractory follicular lymphoma

Trial: ZUMA-5
Drug: Yescarta (axicabtagene ciloleucel) · Anti-CD19 CAR T-cell
Condition: Lymphoid

FDA approves lisocabtagene maraleucel for relapsed or refractory large B-cell lymphoma

Drug: Breyanzi (lisocabtagene maraleucel) · Anti-CD19 CAR T-cell
Condition: Lymphoid

FDA approves brexucabtagene autoleucel for relapsed or refractory mantle cell lymphoma

Trial: ZUMA-2
Drug: TECARTUS (brexucabtagene autoleucel) · Anti-CD19 CAR T-cell
Condition: Lymphoid

FDA approves tisagenlecleucel for adults with relapsed or refractory large B-cell lymphoma

Trial: JULIET
Drug: KYMRIAH (tisagenlecleucel) · Anti-CD19 CAR T-cell
Condition: Lymphoid

FDA approves axicabtagene ciloleucel for large B-cell lymphoma

Drug: YESCARTA (axicabtagene ciloleucel) · Anti-CD19 CAR T-cell
Condition: Lymphoid

FDA approves tisagenlecleucel for B-cell ALL and tocilizumab for cytokine release syndrome

Drug: KYMRIAH (tisagenlecleucel) · Anti-CD19 CAR T-cell
Condition: Lymphoid