On April 3, 2026 Bristol-Myers Squibb Company (Headquarters: Tokyo, Japan) today received approval for a partial amendment to the manufacturing and marketing authorization for its CD19-targeted CAR T-cell therapy, "Breyangi Injection" (generic name: lysokabutagen maralucell, hereinafter "Breyangi"), for the treatment of relapsed or refractory marginal zone lymphoma (hereinafter, MZL) and relapsed or refractory mantle cell lymphoma (hereinafter, MCL). This approval will allow Breyanzi to be offered as a treatment option for relapsed or refractory MCL regardless of the number of prior treatment lines, and for relapsed or refractory MZL from the third line of treatment onward.
This adds a new option to these disease areas where there remains a high level of unmet medical need.
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MZL and MCL are both B-cell lymphomas that fall under the category of non-Hodgkin lymphoma. MZL is a subtype that accounts for about 7% of all non-Hodgkin lymphomas. While many patients achieve remission with initial treatment, relapses are not uncommon, and there has been a need for new treatment options that provide long-term, sustained therapeutic effects. In addition, some cases of MZL can progress to diffuse large B-cell lymphoma, which is a more aggressive form of lymphoma.
MCL is a highly malignant and rare form of non-Hodgkin lymphoma, accounting for approximately 3% of all non-Hodgkin lymphomas. It originates from cells that make up the "mantle zone" of the lymph nodes. The average age at diagnosis is in the mid-60s, and it is more common in the elderly. There is no established standard treatment for MCL that can be expected to cure the disease, and ultimately, disease progression or recurrence occurs. Treatment options for relapsed or refractory MCL are limited.
This approval is based on efficacy and safety results obtained in the MZL cohort of the international collaborative Phase II clinical trial (TRANSCEND FL trial) for patients with relapsed or refractory low-grade B-cell non-Hodgkin lymphoma, and in the MCL cohort of the overseas Phase I clinical trial (TRANSCEND NHL 001 trial) for patients with relapsed or refractory B-cell non-Hodgkin lymphoma.
Angela Davis, Head of Research and Development at Bristol-Myers Squibb Company, stated:
"This approval further expands the indications for Breyange as a CD19-targeted CAR T-cell therapy for B-cell malignancies.
This new single-dose CAR T-cell therapy is highly significant for patients with relapsed or refractory MCL and MZL who have received multiple treatments.
Bristol-Myers Squibb will continue to drive the development and delivery of innovative cell therapies worldwide, aiming to bring long-term benefits to patients facing serious illnesses."
About the TRANSCEND FL trial (Marginal Zone Lymphoma (MZL))
The TRANSCEND FL trial is a phase II, open-label, multicenter study evaluating the efficacy and safety of Breyanzi. Cohort 4 (patients with MZL prior to two or more systemic therapies) includes 67 adult patients with relapsed or refractory indolent B-cell NHL (65 non-Japanese patients and 2 Japanese patients).
The primary endpoint is the overall response rate (ORR), while secondary endpoints include the complete response rate (CRR), duration of response (DOR), DOR in patients who achieved complete response (CR), progression-free survival (PFS), overall survival (OS), safety, and cytokinetics, among others.
In the efficacy analysis population of 66 patients (including 2 Japanese patients) treated with Breyanzi, the primary endpoint, the overall response rate (95% CI), was 95.5% (87.3-99.1), which was statistically significant against the threshold of 50% (p<0.0001). Both Japanese patients showed a response. The
safety profile was consistent with previously reported findings, and no new safety signals were observed.
About the TRANSCEND NHL 001 trial (Mantle cell lymphoma (MCL))
The TRANSCEND NHL 001 trial is a phase I, open-label, multicenter study evaluating the efficacy and safety of Breyanzi. The MCL cohort (patients with MCL prior to two or more systemic therapies) includes 88 adult patients with relapsed or refractory B-cell non-Hodgkin lymphoma (NHL). Patients with one or more prior systemic therapies were also included, although they were not the primary target for the efficacy analysis.
The primary endpoints are safety and overall response rate (ORR), while secondary endpoints include complete response rate (CRR), duration of response (DOR), progression-free survival (PFS), PFS ratio, overall survival (OS), changes in health-related quality of life, and cellular dynamics.
In the primary efficacy analysis population of 74 patients (including only those who received 100 × 10⁶ CAR-expressing live T cells and had received two or more prior systemic therapies, including alkylating agents, Bruton’s tyrosine kinase inhibitors, and rituximab (or other CD20-targeted drugs)), the overall response rate (95% CI), which was the primary endpoint, was 86.5% (76.5–93.3), and the lower limit of the 95% CI was statistically significant against the pre-defined threshold of 40% (p<0.0001). In addition, in the efficacy analysis population of 77 patients (including those who received 100 × 10⁶ CAR-expressing live T cells and had received one or more prior systemic therapies), the ORR (95% CI) was 87.0% (77.4–93.6).
The safety profile was consistent with previously reported findings, and no new safety signals were observed.
(Press release, Bristol-Myers Squibb, APR 3, 2026, View Source [SID1234665483])