FDA Grants Orphan Drug Designation to CLLS52 (alemtuzumab) For ALL Treatment
“We are excited that the FDA granted CLLS52 (alemtuzumab) ODD designation status. The importance of adding alemtuzumab to the lymphodepletion regimen has been demonstrated in Cellectis’ BALLI-01 study, where the addition of this lymphodepletion agent to the fludarabine and cyclophosphamide regimen was associated with sustained lymphodepletion and significantly higher UCART22 cell expansion allowing for greater clinical activity”, said Mark Frattini, M.D., Ph.D. Chief Medical Officer at Cellectis.
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