FDA Approves Lisocabtagene Maraleucel for Treatment of Relapsed/Refractory Mantle Cell Lymphoma


Lisocabtagene maraleucel (Breyanzi; Bristol Myers Squibb) is a CD19-directed CAR T-cell therapy that is delivered as a one-time infusion.

Updated on May 30, 2024, at 2:46 pm.

The FDA approved lisocabtagene maraleucel (liso-cel, Breyanzi; Bristol Myers Squibb) for the treatment of relapsed or refractory mantel cell lymphoma (MCL) for adults who received at least 2 prior lines of systemic therapy, including a Bruton tyrosine kinase (BTK), according to a news release. Liso-cel (Breyanzi; Bristol Myers Squibb) is a CD19-directed chimeric antigen receptor (CAR) T-cell therapy and delivered as a one-time infusion.1

Red blood cells travel in an artery. Hematology, Lymphoma. | Image Credit: DIgilife - stock.adobe.com

Image Credit: DIgilife - stock.adobe.com

“The approval of [liso-cel] brings a new CAR T cell therapy option to patients battling relapsed or refractory MCL,” Meghan Gutierrez, CEO of the Lymphoma Research Foundation, said in the news 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.”1

The approval was based on results from the MCL cohort in the TRANSCEND NHL 001 (NCT02631044) trial and marks the fourth approval for liso-cell in distinct subtypes of non-Hodgkin lymphoma. Investigators of the study included individuals aged 18 years and older with relapsed or refractory MCL, which was confirmed with cyclin D1 expression or evident based on cytogenetics, fluorescents in situ hybridization, or polymerase chain reaction. Investigators also had at least 2 prior lines of systemic therapy, including an alkylating agent, BTK inhibitor, and rituximab or other CD20-targeting agents, according to the study information.1,2

The study was a phase 1 open-label trial focusing on the safety, pharmacokinetics, and antitumor activity for patients with relapsed or refractory B-cell NHL.3

Investigators administered liso-cell as either a single intravenous (IV) injection or as 2 IV injections as treatment arms. They measured treatment related adverse events (AEs), dose-limiting toxicities, objective response rate (ORR), complete response (CR), duration of response (DOR), progression-free survival, overall survival, health-related quality of life, maximum concentration of the drug in peripheral blood, time to maximum concentration, and area under the concentration vs time curve, according to the clinical trial information.2

In 2023, the results showed that there was an ORR of 86.5%, with 74.3% of patients achieving a CR. Median time to response was 1 month, with DOR being 13.3 months, including a 22.2 month follow-up.1,4

Furthermore, liso-cel had a consistent safety profile, with any grade cytokine release syndrome occurring in 54% of patients, and a grade 3 or higher occurring in 3.2% of patients. Median time to onset was 5 days, according to the new release. Additionally, any grade neurologic events were reported in 31% of patients, with a grade 3 or higher occurring in 10% of patients.1

“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, Puddin Clarke Endowed Professor in the Department of Lymphoma and Myeloma in the Division of Cancer Medicine at University of Texas MD Anderson Cancer Center, Houston, Texas, said in the new release. “The approval of [liso-cel] 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.”1

1. U.S. Food and Drug Administration approves Bristol Myers Squibb’s Breyanzi as a new CAR T cell therapy for relapsed or refractory mantle lell 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
2. Study evaluating the safety and pharmacokinetics of JCAR017 in B-cell non-Hodgkin lymphoma (TRANSCEND-NHL-001). ClinicalTrials.gov Identifier: NCT02631044. Updated March 27, 2024. Accessed May 30, 2024. https://clinicaltrials.gov/study/NCT02631044
3. Hunter E. Lisocabtagene maraleucel showed statistically significant response in certain R/R lymphomas. Pharmacy Times®. May 4, 2023. Accessed May 30, 2024. https://www.pharmacytimes.com/view/lisocabtagene-maraleucel-showed-statistically-significant-response-in-certain-r-r-lymphomas
4. Halpern L. Liso-cel produces deep, durable responses in patients with hard-to-lreat Lymphomas. Pharmacy Times. June 22, 2023. Accessed May 30, 2024. https://www.pharmacytimes.com/view/liso-cel-produces-deep-durable-responses-in-patients-with-hard-to-treat-lymphomas
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