Liso-Cel Receives Accelerated Approval for Relapsed or Refractory Follicular Lymphoma

The US Food and Drug Administration (FDA) has granted accelerated approval for lisocabtagene maraleucel (liso-cel), an anti-CD19 chimeric antigen receptor (CAR) T-cell therapy developed by Bristol Myers Squibb under the name Breyanzi®.

Liso-cel is now approved for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more prior lines of systemic therapy. Liso-cel has also been included in the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology for B-cell lymphomas with a category 2A recommendation for third-line and beyond therapy.

Accelerated Approval of Liso-Cel for Follicular Lymphoma

The FDA’s decision was based on data from the phase II TRANSCEND FL study, in which liso-cel achieved an overall response rate of 95.7% (95% CI, 89.5-98.8), and a complete response rate of 73.4% (95% CI, 63.2-82.0) as confirmed by bone marrow biopsy. The median time to response after infusion was one month (range, 0.6-3.3) with 80.9% of responders maintaining a response at 12 months and 77.1% maintaining a response at 18 months.

“In the treatment of relapsed or refractory FL, patients often cycle through treatments with typically shorter responses with each new line of therapy. Those who have experienced early disease progression have notably poor prognosis,” said Maria Lia Palomba, MD, of Memorial Sloan Kettering Cancer Center. “The FDA approval of liso-cel for patients with relapsed or refractory FL is an important advancement in addressing an ongoing unmet need in the FL treatment paradigm, providing patients a new option that has shown remarkably high response rates and an established safety profile.”

Further approval for liso-cel may be dependent on additional confirmatory clinical trials, according to a Bristol Myers Squibb press release.

Related: Liso-Cel ‘Favorable’ Safety Profile in Second-line Follicular Lymphoma