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On May 3, 2023, it was announced that lisocabtagene maraleucel (liso-cel), a CD19-directed chimeric antigen receptor (CAR) T-cell therapy, received approval from the European Commission (EC) for the treatment of adult patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL), high grade B-cell lymphoma (HGBCL), primary mediastinal large B-cell lymphoma (PMBCL), and follicular lymphoma Grade 3B (FL3B) after one prior therapy.1
This approval is based on results from the phase III TRANSFORM trial (NCT03575351),1 in which liso-cel was compared with standard therapy. Below, we report the key data:
Liso-cel showed improved EFS compared to standard of care with a manageable safety profile.1 These data support the use of liso-cel as a second-line treatment for patients with primary refractory or early relapsed LBCL.2
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Lisocabtagene maraleucel as second-line therapy for adult patients with LBCL: Primary analysis of the phase III TRANSFORM trial
Primary analysis of the phase III TRANSFORM trial indicates that liso-cel has superior efficacy to standard of care for...
Lisocabtagene maraleucel receives FDA approval for the second-line treatment of large B-cell lymphoma
On June 24, 2022, it was announced that the U.S. Food and Drug Administration (FDA) had granted approval to lisocabtagene maraleucel (liso-cel), a...
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