BREYANZI is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B, who have:
Limitations of Use: BREYANZI is not indicated for the treatment of patients with primary central nervous system lymphoma.
Patient Identification
In the 3rd line TRANSCEND trial, patients were refractory or relapsed after ≥2 prior therapies, ≥18 years old, ECOG PS 0-1†, LVEF ≥40%, CrCl >30 mL/min, ALT ≤5 × ULN.1
* PILOT criteria included ALT/AST.
† There were 4 patients (1.5%) with ECOG PS 2.
ALT, alanine transaminase; CAR, chimeric antigen receptor; CrCl, creatinine clearance; DLCO, diffusing capacity for carbon monoxide; ECOG PS, Eastern Cooperative Oncology Group performance status; LVEF, left ventricular ejection fraction; ULN, upper limit of normal.
Joseph*
* Hypothetical patient.
Response to prior therapy
First-line therapy
Additional risk factors
Clinical fitness at second line
CrCl, creatinine clearance; DLBCL, diffuse large B-cell lymphoma; ECOG PS, Eastern Cooperative Oncology Group performance status; LDH, lactate dehydrogenase; LVEF, left ventricular ejection fraction; NHL, non-Hodgkin lymphoma.
Susan*
* Hypothetical patient.
Response to prior therapy
First-line therapy
Additional risk factors
Clinical fitness at second line
CR, complete response; CrCl, creatinine clearance; DLBCL, diffuse large B-cell lymphoma, ECOG PS, Eastern Cooperative Oncology Group performance status; LVEF, left ventricular ejection fraction; NOS, not otherwise specified.
Frank*
* Hypothetical patient.
Response to prior therapy
First-line therapy
Additional risk factors
Clinical fitness at second line
CrCl, creatinine clearance; ECOG PS, Eastern Cooperative Oncology Group performance status; HGBCL, high-grade B-cell lymphoma; LVEF, left ventricular ejection fraction.
Michael*
* Hypothetical patient.
Response to prior therapy
First-line therapy
Additional risk factors
Clinical fitness at second line
CR, complete response; CrCl, creatinine clearance, DLCBL, diffuse large B-cell lymphoma, EGOC PS, Eastern Cooperative Oncology Group performance status; LVEF, left ventricular ejection fraction; NOS, not otherwise specified.
Robin*
* Hypothetical patient.
Response to prior therapy
First-line therapy
Second-line therapy
Additional risk factors
Clinical fitness at second line
ASCT, autologous stem cell transplant; CR, complete response; CrCl, creatinine clearance; DLBCL, diffuse large B-cell lymphoma; ECOG PS, Eastern Cooperative Oncology Group performance status; LVEF, left ventricular ejection fraction.
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