FDA Approves Liso-Cel for Relapsed/Refractory Mantle Cell Lymphoma


This marks the only CAR T-cell therapy approved by the FDA for 4 subtypes of non-Hodgkin lymphoma.

FDA Approves Liso-Cel for Relapsed/Refractory Mantle Cell Lymphoma

FDA Approves Liso-Cel for Relapsed/Refractory Mantle Cell Lymphoma

The FDA approved lisocabtagene maraleucel (liso-cel; Breyanzi) for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) treated with at least 2 prior lines of systemic therapy including a Bruton tyrosine kinase (BTK) inhibitor.

The approval of this CD19-directed CAR T-cell therapy marks the fourth subtype of non-Hodgkin lymphoma it is indicated for, according to a press release from Bristol Myers Squibb.

Liso-cel’s approval was based on findings from the MCL cohort of the TRANSCEND NHL 001 trial (NCT02631044). In particular, the cohort included adults with relapsed or refractory MCL who previously received at least 2 prior lines of therapy including a BTK inhibitor.

Of the 68 patients treated with liso-cel and evaluated for efficacy, 85.3% (95% CI, 74.6%-92.7%) experienced a response to treatment, of whom 67.6% (95% CI, 55.2%-78.5%) achieved a complete response. These responses were assessed by the 2014 Lugano classification and was confirmed by a bone marrow biopsy.

The median time to response was 1 month (range: 0.7-3) with a median duration of response of 13.3 months (95% CI, 6.0-23.3) during a median follow-up of 22.2 months (95% CI, 16.7-22.8). At the 12-month mark, 51.4% of patients who responded (95% CI, 37.5%-63.7%) remained in response, whereas 38.8% of responders (95% CI, 25.0%-52.4%) remained in response at 18 months.

Patients with MCL in the TRANSCEND NHL 001 trial had an overall response rate of 83.1% (95% CI, 73.3%-90.5%) with a complete response rate of 72.3% (95% CI, 61.4%-81.6%). The median progression-free survival was 15.3 months (95% CI, 6.6-24.9), and the median duration of response was 15.7 months (95% CI, 6.2-24.0).

“There have been few advances in the treatment of relapsed or refractory MCL, and prognosis worsens for patients after each subsequent relapse, often leaving them with high disease burden and difficulty achieving deep and durable responses,” Michael Wang, MD, lead investigator and Puddin Clarke Endowed Professor, Department of Lymphoma and Myeloma, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center in Houston, said in the release. “The approval of Breyanzi offers an important new CAR T treatment option with high rates of lasting responses and a consistent safety profile, which is critically important for these patients who currently have limited options to treat this aggressive disease.”

Liso-cel demonstrated a consistent safety profile across clinical trials with 702 patients. Cytokine release syndrome occurred in 54% of patients, which included grade 3 or higher cytokine release syndrome in 3.2% of patients. The median time to the onset of cytokine release syndrome was 5 days (range: 1-63). In addition, any-grade neurologic events occurred in 31% of patients, with 10% of those patients experiencing events grade 3 or higher. Neurologic events occurred at a median time to onset of 8 days (range: 1-63), and the majority of patients (88%) experienced resolution of their neurologic events at a median duration of 7 days (range: 1-119). The release noted that this safety profile allows for the treatment of patients with liso-cel in an outpatient setting.

“With Breyanzi, we are delivering on the promise of cell therapy by offering a definitive treatment option for some of the most difficult-to-treat lymphomas,” Bryan Campbell, senior vice president, Head of Commercial, Cell Therapy, Bristol Myers Squibb, said in the release.

Liso-cel is administered as a 1-time infusion of a single dose of 90 to 110 x 106 CAR-positive viable cells. Of note, there is a Boxed Warning for liso-cel for cytokine release syndrome, secondary hematologic malignancies, and neurologic toxicities.

“The approval of Breyanzi brings a new CAR T-cell therapy option to patients battling relapsed or refractory MCL,” Meghan Gutierrez, chief executive officer, Lymphoma Research Foundation, said in the release. “Each advance in treatment represents important progress in improving outcomes for patients, and this news builds upon this progress with a new potentially transformative treatment where there are currently limited options.”


U.S. Food and Drug Administration Approves Bristol Myers Squibb’s Breyanzi as a New CAR T Cell Therapy for Relapsed or Refractory Mantle Cell Lymphoma. News release. Bristol Myers Squibb. May 30, 2024. Accessed May 30, 2024. https://news.bms.com/news/corporate-financial/2024/U.S.-Food-and-Drug-Administration-Approves-Bristol-Myers-Squibbs-Breyanzi-as-a-New-CAR-T-Cell-Therapy-for-Relapsed-or-Refractory-Mantle-Cell-Lymphoma/default.aspx

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