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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.
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
ZYNTEGLO (betibeglogene autotemcel)bluebird bio, Inc.
ZOLGENSMA (onasemnogene abeparvovec-xioi)Novartis Gene Therapies, Inc.

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