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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 CD19-directed chimeric antigen receptor (CAR) T-cell product, for the treatment of relapsed or refractory large B-cell lymphoma in adult patients who have already received ≥1 line of systemic therapy. The approval is based on key data obtained from the phase III TRANSFORM and phase II PILOT studies (NCT03575351; NCT03483103). 1
The approval encompasses patients with diffuse large B-cell lymphoma not otherwise specified, high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma Grade 3B, who have:
Liso-cel has demonstrated deep and durable responses in these patient groups, while also exhibiting a tolerable safety profile. The approval comes shortly after news of the European Commission approval of liso-cel for the ≥3rd line treatment of certain forms of relapsed or refractory large B-cell lymphoma, as previously reported on the Lymphoma Hub.
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Two-year follow-up of TRANSCEND NHL 001 suggests lisocabtagene maraleucel maintains a durable response in R/R large B-cell lymphoma
Liso-cel demonstrated durable remission rates and a promising safety profile in the 2-year follow-up of TRANSCEND NHL...
Lisocabtagene maraleucel receives European Commission approval as ≥ third-line treatment for certain forms of relapsed or refractory large B-cell lymphoma
Liso-cel is a CD19-directed chimeric antigen receptor (CAR) T-cell therapy with a 4-1BB...
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