Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has granted 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 (R/R) marginal zone lymphoma (MZL) who have received at least two prior lines of systemic therapy. Breyanzi is administered as a one-time infusion.
In the MZL cohort of the TRANSCEND FL study, any grade cytokine release syndrome (CRS) occurred in 76% of patients, including Grade 3 CRS in 4.5% of patients. Breyanzi is broadly covered by commercial and government insurance programs in the U.S.Bristol Myers Squibss offers various programs and resources to address the needs of patients and care partners that support their CAR T cell therapy treatment journey. BreyanziU.S. FDA-Approved Indications: 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: refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoim immunotherapy; or refractory disease to first theline chemoimmunotherapy and are not eligible for hematopoietic stem cell transplantation (HSCT) due to comorbidities or age; or relapsed or refractory disease after two or more lines of systemic therapy.
In clinical trials of BREYANZI, which enrolled a total of 769 patients with non-Hodgkin lymphoma (NHL), CRS occurred in 56% of patients, including Grade 3 CRS in 3.4% of patients. In clinical trials of BREyANZI, CAR T cell-associated neurologic toxicities occurred in 32% of patients, including grade 3 cases in 10% of patients. In clinical trial of BREYANZI, infections of any grade occurred in 33% of patients, with Grade 3 or higher infections occurring in 12% of all patients.
In clinical trials of BreYANZI, Grade 3 or higher cytopenias persisted at Day 29 following BREYANZI infusion in 35% of patients, and included thrombocytopenia in 25%, neutropenia in 22%, and anemia in 6% of patients. In clinical studies of BREYANZI, hypogammaglobulinemia was reported as an adverse reaction in 9% of patients.
