Approved Cellular and Gene Therapy Products
Below is a list of licensed products from the Office of Tissues and Advanced Therapies (OTAT).
Approved Products
- ABECMA (idecabtagene vicleucel)
Celgene Corporation, a Bristol-Myers Squibb Company - ADSTILADRIN (nadofaragene firadenovec-vcng)
Ferring Pharmaceuticals A/S - ALLOCORD (HPC, Cord Blood)
SSM Cardinal Glennon Children's Medical Center - AMTAGVI (lifileucel)
Iovance Biotherapeutics, Inc. - BREYANZI (lisocabtagene maraleucel)
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company - CARVYKTI (ciltacabtagene autoleucel)
Janssen Biotech, Inc. - CASGEVY (exagamglogene autotemcel [exa-cel])
Vertex Pharmaceuticals Incorporated - CLEVECORD (HPC Cord Blood)
Cleveland Cord Blood Center - Ducord, HPC Cord Blood
Duke University School of Medicine - ELEVIDYS (delandistrogene moxeparvovec-rokl)
Sarapeta Therapeutics, Inc. - GINTUIT (Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen)
Organogenesis Incorporated - HEMACORD (HPC, cord blood)
New York Blood Center - HEMGENIX (etranacogene dezaparvovec-drlb)
CSL Behring LLC - HPC, Cord Blood
Clinimmune Labs, University of Colorado Cord Blood Bank - HPC, Cord Blood - MD Anderson Cord Blood Bank
MD Anderson Cord Blood Bank - HPC, Cord Blood - LifeSouth
LifeSouth Community Blood Centers, Inc. - HPC, Cord Blood - Bloodworks
Bloodworks - IMLYGIC (talimogene laherparepvec)
BioVex, Inc., a subsidiary of Amgen Inc. - KYMRIAH (tisagenlecleucel)
Novartis Pharmaceuticals Corporation - LANTIDRA (donislecel)
CellTrans Inc. - LAVIV (Azficel-T)
Fibrocell Technologies - LENMELDY (atidarsagene autotemcel)
Orchard Therapeutics (Europe) Limited - LUXTURNA (voretigene neparvovec-rzyl)
Spark Therapeutics, Inc. - LYFGENIA (lovotibeglogene autotemcel [lovo-cel])
bluebird bio, Inc. - MACI (Autologous Cultured Chondrocytes on a Porcine Collagen Membrane)
Vericel Corp. - OMISIRGE (omidubicel-onlv)
Gamida Cell Ltd. - PROVENGE (sipuleucel-T)
Dendreon Corp. - RETHYMIC (allogeneic processed thymus tissue – agdc)
Enzyvant Therapeutics GmbH - ROCTAVIAN (valoctocogene roxaparvovec-rvox)
BioMarin Pharmaceutical Inc - SKYSONA (elivaldogene autotemcel)
bluebird bio, Inc. - STRATAGRAFT (allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen-dsat)
Stratatech Corporation - TECARTUS (brexucabtagene autoleucel)
Kite Pharma, Inc. - VYJUVEK (beremagene geperpavec)
Krystal Biotech, Inc. - YESCARTA (axicabtagene ciloleucel)
Kite Pharma, Incorporated - ZYNTEGLO (betibeglogene autotemcel)
bluebird bio, Inc. - ZOLGENSMA (onasemnogene abeparvovec-xioi)
Novartis Gene Therapies, Inc.