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On May 28, 2022, it was announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for the use of tisagenlecleucel, a chimeric antigen receptor (CAR) T-cell product, for the treatment of adult patients with relapsed or refractory follicular lymphoma who have previously received ≥2 lines of systemic therapy.1 To conform with the accelerated approval program, continued approval in this setting may be dependent upon verification and proven clinical benefit in a confirmatory trial(s). This approval marks the third indication that tisagenlecleucel has received FDA approval for, and it remains the only CAR T-cell therapy approved in both adult and pediatric settings. The approval is based on pivotal data obtained from the phase II ELARA trial (NCT03568461),1 previously reported on the Lymphoma Hub.
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CAR T-cell updates from ZUMA-5 and ELARA trials
Relapse following standard therapeutic approaches is common in patients with advanced-stage, indolent non-Hodgkin lymphomas (iNHL).
SOHO 2019 | How could patients benefit from "point-of-care" CAR T-cell therapy?
At SOHO 2019, Dr Boro Dropulic spoke to the Lymphoma Hub about how patients benefit from "point-of-care" CAR T-cell therapy: lower cost, fewer logistical problems and...
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