MedPath

Lisocabtagene maraleucel

Generic Name
Lisocabtagene maraleucel
Brand Names
Breyanzi
Drug Type
Biotech
Chemical Formula
-
CAS Number
-
Unique Ingredient Identifier
7K2YOJ14X0
Background

Lisocabtagene maraleucel is a chimeric antigen receptor (CAR) T-cell therapy, similar to brexucabtagene autoleucel and axicabtagene ciloleucel. Lisocabtagene maraleucel is a genetically modified autologous T-cell therapy that targets CD19, the B-lymphocyte surface antigen B4.

CAR T-cell therapy has changed the treatment of B-cell lymphomas, significantly increasing survival rates over standard therapy. However, data on the efficacy of CAR T-cell therapies on less severe forms of B-cell lymphoma are lacking. Despite the adverse reactions, the majority of patients given lisocabtagene maraleucel reported an overall increase in quality of life over a 1 year period.

Lisocabtagene maraleucel was granted FDA approval on 5 February 2021 and EC approval on 5 April 2022. It was later granted Health Canada approval on 6 May 2022.

Indication

Lisocabtagene maraleucel is indicated to treat adults with relapsed or refractory large B-cell lymphoma after ≥2 systemic therapies, diffuse large B-cell lymphoma, high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and grade 3B follicular lymphoma.

Associated Conditions
Grade 3b Follicular Lymphoma, High-grade B Cell Lymphoma (HGBCL), Primary Mediastinal (Thymic) Large B Cell Lymphoma (PMBCL), Refractory Diffuse Large B Cell Lymphoma (DLBCL), Refractory Large B-cell Lymphoma, Relapsed Diffuse Large B-cell Lymphoma (DLBCL)
Associated Therapies
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Lisocabtagene maraleucel (liso-cel) improved response outcomes in relapsed/refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) patients, with consistent results across high-risk features. Lower tumor burden and fewer prior treatments correlated with better responses. The objective response rate (ORR) and complete response (CR) rates varied by disease characteristics, but overall, liso-cel showed efficacy even in high-risk patients. Inflammatory markers, bulky disease, and lower creatine clearance rates increased the risk of neurological toxicity.
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