Liso-Cel Approved by FDA for Relapsed or Refractory MCL

By Melissa Badamo - Last Updated: May 30, 2024

The US Food and Drug Administration (FDA) has approved lisocabtagene maraleucel (liso-cel; Breyanzi) for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have received at least two prior lines of systemic therapy, according to a press release from Bristol Myers Squibb, the developer of the chimeric antigen (CAR) T-cell therapy.

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Granted under FDA Priority Review, the approval is based on results from the MCL cohort of the TRANSCEND NHL 001 study. In the primary analysis, liso-cel achieved an overall response rate of 83.1% (95% CI, 73.3-90.5), a complete response rate of 72.3% (95% CI, 61.4-81.6), a median duration of response of 15.7 months (95% CI, 6.2-24.0), and a progression-free survival of 15.3 months (95% CI, 6.6-24.9). Any grade cytokine release syndrome (CRS) occurred in 54% of patients, while grade 3 or higher CRS occurred in 3.2% of patients.

“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,” said Michael Wang, MD, lead investigator of the TRANSCEND NHL 001 study and a Professor in the Department of Lymphoma and Myeloma at the University of Texas MD Anderson Cancer Center, in the press release.

Liso-cel was also approved for chronic lymphocytic leukemia and small lymphocytic lymphoma in March 2024 and follicular lymphoma in May 2024.

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