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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
May 30, 2024 FDA approved lisocabtagene maraleucel (Breyanzi) for adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have received at least two prior lines of systemic therapy, including a Bruton tyrosine kinase inhibitor (BTKi).
May 15, 2024 FDA granted accelerated approval to lisocabtagene maraleucel (Breyanzi) for adults with relapsed or refractory follicular lymphoma (FL) who have received two or more prior lines of systemic therapy.
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.
May 15, 2024 FDA granted accelerated approval to lisocabtagene maraleucel (Breyanzi) for adults with relapsed or refractory follicular lymphoma (FL) who have received two or more prior lines of systemic therapy.
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.
Coding
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