FDA Approves Breyanzi for Relapsed, Refractory MCL

The Food and Drug Administration (FDA) has approved the CAR-T cell therapy Breyanzi (lisocabtagene maraleucel; liso-cel) for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) who received at least two prior lines of systemic therapy, including a Bruton tyrosine kinase (BTK) inhibitor.

Breyanzi manufacturer Bristol Myers Squibb, announcing the approval, noted the agency’s action marked the fourth subtype of non-Hodgkin lymphoma for which Breyanzi has received approval.

“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,” said Dr. Michael Wang, lead investigator and Puddin Clarke Endowed Professor, Department of Lymphoma and Myeloma, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, in the news 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.”

The approval was based on the results of the MCL cohort in the TRANSCEND NHL 001 clinical trial of adults with relapsed or refractory MCL who received at least two previous lines of therapy, including a BTK inhibitor. According to the manufacturer, 85.3% of patients responded to treatment, while 67.6% of patients experienced a complete response (no signs or symptoms of cancer). There was a median time to response of one month and a median duration of response of 13.3 months at a median follow-up of 22.2 months.

At 12 months, 51.4% of responders remained in response, meaning that they did not have any signs or symptoms of cancer. Further, at 18 months 38.8% of responders remained in response.

Across clinical trials any-grade cytokine release syndrome (CRS; a potentially serious condition involving increased inflammatory markers, called cytokines, in the blood) occurred in 54% of patients, with grade 3 (severe) or higher in 3.2% of patients. The median time to onset was five days, the manufacturer reported.

Any-grade neurological events occurred in 31% of patients, with grade 3 or higher in 10% of patients, and a median time to onset of eight days and neurological events resolving with a median duration of seven days in 88% of patients.

“The approval of Breyanzi brings a new CAR-T cell therapy option to patients battling relapsed or refractory MCL,” said Meghan Gutierrez, chief executive officer, Lymphoma Research Foundation, 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. We are thankful for the families and the researchers involved in making this approval a reality for those living with this disease.”

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