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Lisocabtagene maraleucel receives European Commission approval as ≥ third-line treatment for certain forms of relapsed or refractory large B-cell lymphoma
On 5 April, 2022, it was announced that the European Commission (EC) granted marketing authorization for lisocabtagene maraleucel (liso-cel) for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma Grade 3B after ≥2 lines of systemic therapy.
Liso-cel is a CD19-directed chimeric antigen receptor (CAR) T-cell therapy with a 4-1BB costimulatory domain, administered as a defined composition to reduce variability in the CD4 and CD8 component dose. The approval is based on pivotal data obtained from the TRANSCEND WORLD, PLATFORM, OUTREACH and TRANSCEND-NHL-001 clinical trials. In addition to its efficacy in treating relapsed or refractory large B-cell Lymphoma, liso-cel has demonstrated a manageable safety profile in these patient groups.
This cell therapy has previously been approved by the U.S. Food and Drug Administration (FDA) and the Japanese Ministry of Health, Labor, and Welfare.
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