All the Active Ingredient Drugs
Engineered Autologous T Cell Immunotherapy product. lisocabtagene maraleucel 1.1-70 x 10^6 cells/mL. Vial 1X 4.6 ml for IV inf.
For autologous use.
Tmt. consists of a sgle. dose containing a dispersion for inf. of CAR-positive viable T cells in one or more vials.
The target dose is 100 x 106 CAR-positive viable T cells (consisting of a target 1:1 ratio of CD4+ and CD8+ cell components) within a range of 44-120 x 106 CAR-positive viable T cells.
For adult pts. with large B-cell lymphoma (LBCL), incl. diffuse large B-cell lymphoma (DLBCL) not otherwise specified (incl. DLBCL arising from indolent lymphoma), high grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B who have:
refractory dis. to first-line chemoimmunother. or relapse within 12 months of first-line chemoimmunother.; or
refractory dis. to first-line chemoimmunother. or relapse after first-line
chemoimmunother. and are not eligibale for hematopoetic stem cell transplant. (HSCT) due to comorbidities or age.
For adult pts. with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL) and follicular lymphoma grade 3B (FL3B), after two or more lines of systemic ther.
C/I:Hypersens. Contraindic. of the lymphodepleting chemother. must be considered.