An official website of the United States government
Home
Name
Breyanzi
Alternate Names
lisocabtagene maraleucel
Abbreviations
None
Category
Biologic therapy (BRM, immunotherapy)
Subcategory
Anti-CD19-CAR Genetically Engineered Autologous T Lymphocytes
NSC Number
None
Primary Site
None
Histology
Lymphoma
Remarks
March 15, 2024 FDA granted accelerated approval of Breyanzi (lisocabtagene maraleucel;liso-cel), a CD19-directed chimeric antigen receptor CAR T-cell therapy for the treatment of adult patients with relapsed or refractory chronic cytic leukemia or small lymphocytic lymphoma who have received at least two prior lines of therapy, including a Bruton tyrosine kinase inhibitor and a B-cell lymphoma 2 (BCL-2) inhibitor.
February 5, 2021 FDA approved lisocabtagene maraleucel (Breyanzi) for the treatment of adult patients with relapsed or refractory (R/R) large B-cell lymphoma after two or more lines of systemic therapy, 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.
February 5, 2021 FDA approved lisocabtagene maraleucel (Breyanzi) for the treatment of adult patients with relapsed or refractory (R/R) large B-cell lymphoma after two or more lines of systemic therapy, 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.
Coding
This drug should be coded
