BMS Lisocabtagene Maraleucel (Breyanzi) FDA Approval Date and History
BMS Lisocabtagene Maraleucel (Breyanzi) FDA Approval Date and History
Introduction to Breyanzi
Breyanzi (lisocabtagene maraleucel; liso-cel) is a CD19-targeted CAR-T cell therapy with a 4-1BB costimulatory domain, which enhances the expansion and persistence of CAR-T cells. The unique feature of this therapy is the controlled ratio of CD8+ and CD4+ T cells in the CAR-T product, allowing better management of the potential toxicities associated with CAR-T cell therapy.
Breyanzi FDA Approval Date and History
Initial FDA Approval
On February 5, 2021, the FDA initially approved the CAR-T cell therapy Breyanzi (lisocabtagene maraleucel; liso-cel) as a third-line treatment for adult patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B, after two or more lines of systemic therapy. However, Breyanzi is not indicated for the treatment of primary central nervous system lymphoma.
Second FDA Approval
On June 25, 2022, the FDA approved a new indication for the CD19 CAR-T therapy Breyanzi (lisocabtagene maraleucel, liso-cel) as a second-line treatment for adult patients with large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B, in the following settings:
(1) Patients who are refractory to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy;
(2) Patients who are refractory to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are ineligible for hematopoietic stem cell transplantation (HSCT) due to comorbidities or age.
Compared to standard therapy, Breyanzi demonstrated statistically significant and clinically meaningful improvements in event-free survival (EFS), complete response (CR), and progression-free survival (PFS) in LBCL patients who were refractory to or relapsed within 12 months after first-line chemoimmunotherapy.
Third FDA Approval
On March 14, 2024, the FDA announced the accelerated approval of Breyanzi for adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least two prior therapies, including a Bruton’s tyrosine kinase (BTK) inhibitor and a BCL-2 inhibitor. Breyanzi is a CD19-directed CAR-T cell therapy and the first FDA-approved CAR-T cell therapy for the treatment of CLL/SLL.
Fourth FDA Approval
On May 15, 2024, the FDA granted accelerated approval to Bristol Myers Squibb’s CD19 CAR-T cell therapy lisocabtagene maraleucel (liso-cel, Breyanzi) for adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic treatment.
This expanded indication for Breyanzi follows its accelerated approval in March 2024 for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (R/R CLL) or small lymphocytic lymphoma (SLL). Breyanzi is the first FDA-approved CAR-T cell therapy for the treatment of CLL/SLL.