Cellectis Gains FDA Designations for Leukemia Therapy

Cellectis SA (CLLS) has released an update.

Cellectis SA’s UCART22, a gene-edited CAR T-cell product candidate, has received Orphan Drug and Rare Pediatric Disease Designations from the FDA for its potential to treat Acute Lymphoblastic Leukemia (ALL), a rapidly progressing and typically fatal disease if untreated. This recognition could accelerate and reduce costs of development and approval, and suggests UCART22 as a promising therapy for ALL patients who have limited treatment options. Encouraging clinical data indicates a high preliminary response rate, with further updates expected by year-end 2024.

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