BMS Breyanzi FDA Approval History
BMS Breyanzi FDA Approval History
Breyanzi Introduction
Breyanzi (lisocabtagene maraleucel), a CD19-directed chimeric antigen receptor T cell (CAR-T) therapy, developed by Bristol Myers Squibb (BMS), has made significant strides in the field of cancer treatment since its initial FDA approval in 2021. Over the past few years, Breyanzi has expanded its indications, becoming the most broadly applicable CAR-T cell therapy for various types of non-Hodgkin lymphomas. This article delves into Breyanzi’s journey through the FDA approval process, its clinical trial results, and its impact on cancer treatment.
Initial FDA Approval: February 5, 2021
Breyanzi first received FDA approval on February 5, 2021, for the treatment of adult patients with relapsed or refractory large B-cell lymphoma (LBCL) after at least two lines of systemic therapy. This approval was based on the results of the pivotal TRANSCEND NHL 001 study, which demonstrated impressive efficacy and a manageable safety profile. LBCL encompasses various subtypes, including diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma, and high-grade B-cell lymphoma.
Expansion to Second-Line Treatment for LBCL: June 24, 2022
In June 24, 2022, Breyanzi’s approval was expanded to include second-line treatment for LBCL. This decision was supported by data from the TRANSFORM trial, a global phase 3 study. The trial results showed that Breyanzi significantly improved outcomes for patients who had relapsed or were refractory to first-line treatment. This milestone was crucial as it positioned Breyanzi as an early intervention option, potentially improving survival rates and quality of life for patients with aggressive lymphomas.
Approval for CLL/SLL: March 14, 2024
On March 14, 2024, the FDA granted accelerated approval for Breyanzi to treat adults with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who had undergone at least two prior therapies. This approval was primarily based on the findings from the TRANSCEND CLL 004 trial, the first multicenter study evaluating CAR-T therapy in this patient population.
The study reported a complete remission (CR) rate of 20%, with a notable 100% minimal residual disease (MRD) negativity in the blood and 92.3% in the bone marrow among patients who achieved CR. These results underscored the potential of Breyanzi to provide deep and durable remissions in patients with CLL/SLL, a challenging-to-treat group.
Approval for Follicular Lymphoma: May 15, 2024
Breyanzi received FDA approval on May 15, 2024, for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after at least two lines of systemic therapy. This approval was based on the phase 2 TRANSCEND FL study, which demonstrated a high overall response rate (ORR) of 95.7% and a CR rate of 73.4%.
The median time to response was one month, and the median duration of response (DOR) had not been reached at the time of the analysis. The durability of responses was highlighted by 80.9% of patients maintaining their response at 12 months and 77.1% at 18 months. These data were also presented at the 2023 International Conference on Malignant Lymphoma, further establishing Breyanzi’s efficacy in FL.
Approval for Mantle Cell Lymphoma: May 30, 2024
On May 30, 2024, the FDA approved Breyanzi for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two prior lines of systemic therapy. This approval was supported by results from the TRANSCEND NHL 001 study’s MCL cohort.
The study showed an ORR of 85.3% and a CR rate of 67.6%, with a median time to response of one month. The median DOR was reported to be 13.3 months, with 51.4% of patients maintaining their response at 12 months and 38.8% at 18 months. The findings, published in the Journal of Clinical Oncology, highlighted Breyanzi’s potential to provide long-lasting remissions in MCL, a particularly aggressive lymphoma subtype.