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FDA Approved Bristol Myers Squibb’s Breyanzi for Relapsed or Refractory Mantle Cell Lymphoma

In an advancement for patients with mantle cell lymphoma (MCL), the U.S. Food and Drug Administration (FDA) has approved Bristol Myers Squibb’s Breyanzi (lisocabtagene maraleucel) as a new CAR T cell therapy.

This CD19-directed chimeric antigen receptor (CAR) T cell therapy is specifically indicated for adult patients with relapsed or refractory MCL who have previously undergone at least two systemic treatments, including a Bruton tyrosine kinase (BTK) inhibitor.

This approval expands Breyanzi’s reach, making it the only CAR T cell therapy approved for four distinct types of non-Hodgkin lymphoma, thus offering this personalized treatment to the widest range of patients with B-cell malignancies.

The efficacy of Breyanzi in treating relapsed or refractory MCL was demonstrated in the MCL cohort of the TRANSCEND NHL 001 study. This trial included adults with MCL who had not responded to at least two prior therapies, including a BTK inhibitor. Patients received a single infusion of Breyanzi, consisting of 90 to 110 million CAR-positive viable T cells.

According to U.S. Prescribing Information (USPI), 85.3% of the 68 patients evaluated for efficacy responded to the treatment, with 67.6% achieving a complete response. These responses, measured according to the 2014 Lugano classification and confirmed via bone marrow biopsy, were both rapid and durable. The median time to response was one month, and the median duration of response was 13.3 months, with a median follow-up of 22.2 months.

At 12 months, 51.4% of responders maintained their response, and 38.8% did so at 18 months. The overall response rate in the study was 83.1%, with a complete response rate of 72.3%.

Breyanzi’s safety profile has been consistent across clinical trials, including 702 patients. Any grade of cytokine release syndrome (CRS) occurred in 54% of patients, with 3.2% experiencing Grade 3 or higher CRS. The median onset of CRS was 5 days. Neurologic events of any grade were reported in 31% of patients, with 10% experiencing Grade 3 or higher events. These neurologic events had a median onset of 8 days and resolved in 88% of patients within a median duration of 7 days. The safety profile supports the possibility of administering Breyanzi in both inpatient and outpatient settings, as evidenced by the MCL cohort of the TRANSCEND NHL 001 study.

Commercial and government insurance plans in the United States widely cover Breyanzi. Bristol Myers Squibb also offers various programs to assist patients and caregivers in accessing this therapy. Their support includes the Cell Therapy 360 digital service platform, which provides critical information, manufacturing updates, and comprehensive support for patients and caregivers.


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