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  1. Cellular & Gene Therapy Products

Approved Cellular and Gene Therapy Products

Below is a list of licensed products from the Office of Therapeutic Products (OTP).


Approved Products


Product & Trade NameManufacturer
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.
AUCATZYL (obecabtagene autoleucel)Autolus Limited
BEQVEZ (fidanacogene elaparvovec-dzkt)Pfizer, 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 BloodDuke University School of Medicine
ELEVIDYS (delandistrogene moxeparvovec-rokl)Sarapeta Therapeutics, Inc.
ENCELTO (revakinagene taroretcel-lwey)Neurotech Pharmaceuticals, 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 BloodClinimmune Labs, University of Colorado Cord Blood Bank
HPC, Cord Blood - MD Anderson Cord Blood BankMD Anderson Cord Blood Bank
HPC, Cord Blood - LifeSouthLifeSouth Community Blood Centers, Inc.
HPC, Cord Blood - BloodworksBloodworks
IMLYGIC (talimogene laherparepvec)BioVex, Inc., a subsidiary of Amgen Inc.
KEBILIDI (eladocagene exuparvovec-tneq)PTC Therapeutics
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.
REGENECYTE (HPC, Cord Blood)StemCyte, Inc.
RETHYMIC (allogeneic processed thymus tissue – agdc)Enzyvant Therapeutics GmbH
ROCTAVIAN (valoctocogene roxaparvovec-rvox)BioMarin Pharmaceutical Inc
RYONCIL (remestemcel-L-rknd) Mesoblast, Inc.
SYMVESS (acellular tissue engineered vessel-tyod) Humacyte Global, 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.
TECELRA (afamitresgene autoleucel)Adaptimmune LLC
VYJUVEK (beremagene geperpavec)Krystal Biotech, Inc.
YESCARTA (axicabtagene ciloleucel)Kite Pharma, Incorporated
ZEVASKYN (prademagene zamikeracel)Abeona Therapeutics, Inc.
ZYNTEGLO (betibeglogene autotemcel)bluebird bio, Inc.
ZOLGENSMA (onasemnogene abeparvovec-xioi)Novartis Gene Therapies, Inc.

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