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Bristol Myers Squibb’s Breyanzi Approved by the U.S. FDA as the First and Only CAR T Cell Therapy for Adults with Relapsed or Refractory Marginal Zone Lymphoma (MZL)
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The U.S. Food and Drug Administration (FDA) has granted approval for Breyanzi, 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, as announced by Bristol Myers Squibb(BMY).

This significant approval establishes Breyanzi as the first and only CAR T cell therapy approved for R/R MZL, further broadening its reach as a leading treatment for five different B-cell malignancies, administered as a one-time infusion. MZL, an indolent non-Hodgkin lymphoma subtype that accounts for about 7% of all NHL cases, often sees relapse despite initial success, creating a critical need for durable new options.

The approval is supported by data from the MZL cohort of the TRANSCEND FL study, an open-label, multicenter, single-arm trial, which demonstrated an impressive overall response rate (ORR) of 95.5% in the primary efficacy analysis set of 66 patients, with a complete response (CR) rate of 62.1%. Furthermore, the median duration of response (mDOR) was not reached, with 90.1% of responders maintaining their response at 24 months, indicating highly durable outcomes. The safety profile observed in the R/R MZL cohort was consistent with previous trials, with common adverse events including all-grade cytokine release syndrome (CRS) in 76% of patients (Grade geq3 in 4.5%) and various nervous system disorders like headache and tremor, which occurred in the context of a treatment setting that allows for outpatient management for appropriate patients.

Breyanzi is made from a patient’s own T cells, which are collected, reengineered, and then infused, with the entire process encompassing blood collection through side-effect monitoring. Important safety information includes Boxed WARNINGS regarding Cytokine Release Syndrome, Neurologic Toxicities, and Secondary Hematological Malignancies. Bristol Myers Squibb emphasizes its commitment to patient access through broad insurance coverage and support programs like Cell Therapy 360, a digital service platform designed to optimize the patient and physician experience.

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