Approved Cellular and Gene Therapy Products

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aria-hidden="true"></span>Print</a> </li> </ul> <div class="form-group"> </div> </div> </div> </section> </header> <div class="col-md-8 col-md-push-2" role="main"> <p>Below is a list of licensed products from the Office of Therapeutic Products (OTP).</p><hr><h2>Approved Products</h2><hr><div class="table-responsive"><table class="table table-bordered" summary="text showing Below is a list of licensed products from the Office of Therapeutic Products (OTP)"><thead><tr><th scope="col">Product & Trade Name</th><th scope="col">Manufacturer</th></tr></thead><tbody><tr><td><a href="/vaccines-blood-biologics/abecma-idecabtagene-vicleucel" data-entity-type="node" data-entity-uuid="5db3f7ee-add6-41ab-bc4f-06469dcc0371" data-entity-substitution="canonical" title="ABECMA (idecabtagene vicleucel)">ABECMA (idecabtagene vicleucel)</a></td><td>Celgene Corporation, a Bristol-Myers Squibb Company</td></tr><tr><td><a href="/vaccines-blood-biologics/cellular-gene-therapy-products/adstiladrin" data-entity-type="node" data-entity-uuid="66087a9f-8da0-4738-b940-c787ffb6217c" data-entity-substitution="canonical" title="ADSTILADRIN">ADSTILADRIN (nadofaragene firadenovec-vcng)</a></td><td>Ferring Pharmaceuticals A/S</td></tr><tr><td><a href="/vaccines-blood-biologics/cellular-gene-therapy-products/allocord-hpc-cord-blood" data-entity-type="node" data-entity-uuid="de2c3367-359c-46a6-8066-b5f20c52f835" data-entity-substitution="canonical" title="ALLOCORD (HPC Cord Blood)">ALLOCORD (HPC, Cord Blood)</a></td><td>SSM Cardinal Glennon Children's Medical Center</td></tr><tr><td><a href="/vaccines-blood-biologics/approved-blood-products/amtagvi" data-entity-type="node" data-entity-uuid="9dee5095-14b4-4740-abd9-211455ff1cd0" data-entity-substitution="canonical" title="AMTAGVI">AMTAGVI (lifileucel)</a></td><td>Iovance Biotherapeutics, Inc.</td></tr><tr><td><a href="/vaccines-blood-biologics/aucatzyl" data-entity-type="node" data-entity-uuid="4b09e2b9-4a4e-4c8a-ac15-a4bb7a47ad28" data-entity-substitution="canonical" title="AUCATZYL ">AUCATZYL (obecabtagene autoleucel)</a></td><td>Autolus Limited</td></tr><tr><td><a href="/vaccines-blood-biologics/cellular-gene-therapy-products/beqvez" data-entity-type="node" data-entity-uuid="53c1f9ce-dece-4554-8d23-963797cef7a9" data-entity-substitution="canonical" title="BEQVEZ">BEQVEZ (fidanacogene elaparvovec-dzkt)</a></td><td>Pfizer, Inc.</td></tr><tr><td><a href="/vaccines-blood-biologics/cellular-gene-therapy-products/breyanzi-lisocabtagene-maraleucel" data-entity-type="node" data-entity-uuid="6e10f504-874f-43bd-a4f4-2c9aa9d0ecab" data-entity-substitution="canonical" title=" BREYANZI (lisocabtagene maraleucel)">BREYANZI (lisocabtagene maraleucel)</a></td><td>Juno Therapeutics, Inc., a Bristol-Myers Squibb Company</td></tr><tr><td><a href="/vaccines-blood-biologics/cellular-gene-therapy-products/carvykti" data-entity-type="node" data-entity-uuid="0882cc92-f5f6-448d-9685-df79d94e7445" data-entity-substitution="canonical" title="CARVYKTI">CARVYKTI (ciltacabtagene autoleucel)</a></td><td>Janssen Biotech, Inc.</td></tr><tr><td><a href="/vaccines-blood-biologics/casgevy" data-entity-type="node" data-entity-uuid="5c25f61c-ccd4-44f6-8aa7-259461e5350f" data-entity-substitution="canonical" title="CASGEVY">CASGEVY (exagamglogene autotemcel [exa-cel])</a></td><td>Vertex Pharmaceuticals Incorporated</td></tr><tr><td><a href="/vaccines-blood-biologics/cellular-gene-therapy-products/clevecord-hpc-cord-blood" data-entity-type="node" data-entity-uuid="63246953-b009-45ff-8e1a-b9709d7d60ee" data-entity-substitution="canonical" title="CLEVECORD (HPC Cord Blood)">CLEVECORD (HPC Cord Blood)</a></td><td>Cleveland Cord Blood Center</td></tr><tr><td><a href="/vaccines-blood-biologics/cellular-gene-therapy-products/ducord-hpc-cord-blood" data-entity-type="node" data-entity-uuid="ea101c1e-ee2d-493c-94fa-f1d989f65a25" data-entity-substitution="canonical" title="DUCORD (HPC Cord Blood)">Ducord, HPC Cord Blood</a></td><td>Duke University School of Medicine</td></tr><tr><td><a href="/vaccines-blood-biologics/tissue-tissue-products/elevidys" data-entity-type="node" data-entity-uuid="073c7699-2503-48c7-9504-7725bc209b7e" data-entity-substitution="canonical" title=" ELEVIDYS">ELEVIDYS (delandistrogene moxeparvovec-rokl)</a></td><td>Sarapeta Therapeutics, Inc.</td></tr><tr><td><a href="/vaccines-blood-biologics/cellular-gene-therapy-products/gintuit-allogeneic-cultured-keratinocytes-and-fibroblasts-bovine-collagen" data-entity-type="node" data-entity-uuid="8692a1e1-7586-45a5-bd67-44fe212c470a" data-entity-substitution="canonical" title="GINTUIT (Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen)">GINTUIT (Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen)</a></td><td>Organogenesis Incorporated</td></tr><tr><td><a href="/vaccines-blood-biologics/cellular-gene-therapy-products/hemacord-hpc-cord-blood" data-entity-type="node" data-entity-uuid="166dc779-b463-434b-98ec-f012c5a57311" data-entity-substitution="canonical" title="HEMACORD (HPC, cord blood)">HEMACORD (HPC, cord blood)</a></td><td>New York Blood Center</td></tr><tr><td><a href="/vaccines-blood-biologics/vaccines/hemgenix" data-entity-type="node" data-entity-uuid="1c955f76-c3a4-4630-8b63-357351820ab8" data-entity-substitution="canonical" title="HEMGENIX">HEMGENIX (etranacogene dezaparvovec-drlb)</a></td><td>CSL Behring LLC</td></tr><tr><td><a href="/vaccines-blood-biologics/cellular-gene-therapy-products/hpc-cord-blood" data-entity-type="node" data-entity-uuid="ec1e1d33-d850-46ab-8d26-f97ecddeac9f" data-entity-substitution="canonical" title="HPC, Cord Blood">HPC, Cord Blood</a></td><td>Clinimmune Labs, University of Colorado Cord Blood Bank</td></tr><tr><td><a href="/vaccines-blood-biologics/cellular-gene-therapy-products/hpc-cord-blood-md-anderson-cord-blood-bank" data-entity-type="node" data-entity-uuid="af2625d9-2a52-476f-a13e-72b03062fac4" data-entity-substitution="canonical" title="HPC, Cord Blood - MD Anderson Cord Blood Bank">HPC, Cord Blood - MD Anderson Cord Blood Bank</a></td><td>MD Anderson Cord Blood Bank</td></tr><tr><td><a href="/vaccines-blood-biologics/cellular-gene-therapy-products/hpc-cord-blood-lifesouth" data-entity-type="node" data-entity-uuid="665cff3b-54ef-4222-8943-ab1cfa5283d7" data-entity-substitution="canonical" title="HPC, Cord Blood - LifeSouth">HPC, Cord Blood - LifeSouth</a></td><td>LifeSouth Community Blood Centers, Inc.</td></tr><tr><td><a href="/vaccines-blood-biologics/cellular-gene-therapy-products/hpc-cord-blood-bloodworks" data-entity-type="node" data-entity-uuid="8e75d741-f727-4ce1-8aef-c26eb845e1d7" data-entity-substitution="canonical" title="HPC, Cord Blood - Bloodworks">HPC, Cord Blood - Bloodworks</a></td><td>Bloodworks</td></tr><tr><td><a href="/vaccines-blood-biologics/cellular-gene-therapy-products/imlygic" data-entity-type="node" data-entity-uuid="e6c4ab7e-b306-48bf-90ca-6f167c63e88f" data-entity-substitution="canonical" title="IMLYGIC ">IMLYGIC (talimogene laherparepvec)</a></td><td>BioVex, Inc., a subsidiary of Amgen Inc.</td></tr><tr><td><a href="/vaccines-blood-biologics/kebilidi" data-entity-type="node" data-entity-uuid="79988a14-c052-4de2-8376-1d5d0ff28c97" data-entity-substitution="canonical" title="KEBILIDI">KEBILIDI (eladocagene exuparvovec-tneq)</a></td><td>PTC Therapeutics</td></tr><tr><td><a href="/vaccines-blood-biologics/cellular-gene-therapy-products/kymriah" data-entity-type="node" data-entity-uuid="773e9fc8-a923-4564-9668-d5ef27604280" data-entity-substitution="canonical" title="KYMRIAH ">KYMRIAH (tisagenlecleucel)</a></td><td>Novartis Pharmaceuticals Corporation</td></tr><tr><td><a href="/vaccines-blood-biologics/lantidra" data-entity-type="node" data-entity-uuid="23838f1e-6ad4-4581-a1d3-1e3d93c8ab1b" data-entity-substitution="canonical" title="LANTIDRA">LANTIDRA (donislecel)</a></td><td>CellTrans Inc.</td></tr><tr><td><a href="/vaccines-blood-biologics/cellular-gene-therapy-products/laviv" data-entity-type="node" data-entity-uuid="980d2ca6-5fbc-48de-89ee-552ab554a48c" data-entity-substitution="canonical" title="LAVIV ">LAVIV (Azficel-T)</a></td><td>Fibrocell Technologies</td></tr><tr><td><a href="/vaccines-blood-biologics/cellular-gene-therapy-products/lenmeldy" data-entity-type="node" data-entity-uuid="208fabe9-d5c2-4e81-87e8-810744bc3ba7" data-entity-substitution="canonical" title="LENMELDY">LENMELDY (atidarsagene autotemcel)</a></td><td>Orchard Therapeutics (Europe) Limited</td></tr><tr><td><a href="/vaccines-blood-biologics/cellular-gene-therapy-products/luxturna" data-entity-type="node" data-entity-uuid="84745ea1-823d-481e-8a05-82bd69e3c0e6" data-entity-substitution="canonical" title="LUXTURNA">LUXTURNA (voretigene neparvovec-rzyl)</a></td><td>Spark Therapeutics, Inc.</td></tr><tr><td><a href="/vaccines-blood-biologics/lyfgenia" data-entity-type="node" data-entity-uuid="d859bba2-894d-4967-8ec3-9fb775b2e41d" data-entity-substitution="canonical" title="LYFGENIA">LYFGENIA (lovotibeglogene autotemcel [lovo-cel])</a></td><td>bluebird bio, Inc.</td></tr><tr><td><a href="/vaccines-blood-biologics/cellular-gene-therapy-products/maci-autologous-cultured-chondrocytes-porcine-collagen-membrane" data-entity-type="node" data-entity-uuid="3249e09a-bd0f-4ab8-97a4-8b5de5a498d8" data-entity-substitution="canonical" title="MACI (autologous cultured chondrocytes on porcine collagen membrane)">MACI (Autologous Cultured Chondrocytes on a Porcine Collagen Membrane)</a></td><td>Vericel Corp.</td></tr><tr><td><a href="/vaccines-blood-biologics/omisirge" data-entity-type="node" data-entity-uuid="f33d0989-2147-4a10-b1fc-c51c3c451f77" data-entity-substitution="canonical" title="OMISIRGE">OMISIRGE (omidubicel-onlv)</a></td><td>Gamida Cell Ltd.</td></tr><tr><td><a href="/vaccines-blood-biologics/cellular-gene-therapy-products/provenge-sipuleucel-t" data-entity-type="node" data-entity-uuid="0e9d6c73-b873-48ff-816c-d8bc746efb5c" data-entity-substitution="canonical" title="PROVENGE (sipuleucel-T)">PROVENGE (sipuleucel-T)</a></td><td>Dendreon Corp.</td></tr><tr><td><a href="/vaccines-blood-biologics/cellular-gene-therapy-products/regenecyte" data-entity-type="node" data-entity-uuid="02139eb1-5d70-47e4-bb79-e4c66974e8f9" data-entity-substitution="canonical" title="REGENECYTE">REGENECYTE (HPC, Cord Blood)</a></td><td>StemCyte, Inc.</td></tr><tr><td><a href="/vaccines-blood-biologics/rethymic" data-entity-type="node" data-entity-uuid="d2654506-d3f5-4cc1-ad36-52119b2fad47" data-entity-substitution="canonical" title="RETHYMIC">RETHYMIC (allogeneic processed thymus tissue – agdc)</a></td><td>Enzyvant Therapeutics GmbH</td></tr><tr><td><a href="/vaccines-blood-biologics/roctavian" data-entity-type="node" 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autotemcel)</a></td><td>bluebird bio, Inc.</td></tr><tr><td><a href="/vaccines-blood-biologics/stratagraft" data-entity-type="node" data-entity-uuid="d6a30591-a709-45aa-b657-8b9d712401ad" data-entity-substitution="canonical" title="STRATAGRAFT">STRATAGRAFT (allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen-dsat)</a></td><td>Stratatech Corporation</td></tr><tr><td><a href="/vaccines-blood-biologics/cellular-gene-therapy-products/tecartus" data-entity-type="node" data-entity-uuid="6dda83bf-1d7d-4228-a036-8a78e3d64625" data-entity-substitution="canonical" title="TECARTUS">TECARTUS (brexucabtagene autoleucel)</a></td><td>Kite Pharma, Inc.</td></tr><tr><td><a href="/vaccines-blood-biologics/cellular-gene-therapy-products/tecelra" data-entity-type="node" data-entity-uuid="d31a81a8-d1ca-44a6-aea5-8bfba4bc9986" data-entity-substitution="canonical" title=" TECELRA">TECELRA (afamitresgene autoleucel)</a></td><td>Adaptimmune LLC</td></tr><tr><td><a href="/vaccines-blood-biologics/vyjuvek" data-entity-type="node" data-entity-uuid="002565b4-abdb-471d-8cd1-05b6a60098ec" data-entity-substitution="canonical" title="VYJUVEK">VYJUVEK (beremagene geperpavec)</a></td><td>Krystal Biotech, Inc.</td></tr><tr><td><a href="/vaccines-blood-biologics/cellular-gene-therapy-products/yescarta" data-entity-type="node" data-entity-uuid="39379375-62c5-40b5-b8a7-22c53b113f3b" data-entity-substitution="canonical" title="YESCARTA">YESCARTA (axicabtagene ciloleucel)</a></td><td>Kite Pharma, Incorporated</td></tr><tr><td><a href="/vaccines-blood-biologics/zynteglo" data-entity-type="node" data-entity-uuid="553a8b2b-c527-4f74-bc24-eaf1398a0e01" data-entity-substitution="canonical" title="ZYNTEGLO">ZYNTEGLO (betibeglogene autotemcel)</a></td><td>bluebird bio, Inc.</td></tr><tr><td><a href="/vaccines-blood-biologics/zolgensma" data-entity-type="node" data-entity-uuid="7dbc97c8-67e6-4e4b-bd8b-d44e7ce2b053" data-entity-substitution="canonical" title="ZOLGENSMA">ZOLGENSMA (onasemnogene abeparvovec-xioi)</a></td><td>Novartis Gene Therapies, Inc.</td></tr></tbody></table></div>   </div> <aside class="col-md-2 col-md-push-2" role="complementary"> <section id="block-entityviewcontent-4" data-block-plugin-id="entity_view:node" class="block block-ctools block-entity-viewnode clearfix"> <div class="region region-"> <aside class="lcds-card lcds-card--border-top"> <ul role="menu" class="lcds-description-list"> <li role="menuitem" class="node-current-date lcds-description-list__item"> <div> <h2 class="lcds-description-list__item-heading">Content current as of:</h2> <p class="lcds-description-list__item-text"><time datetime="2024-12-20T00:00:00Z">12/20/2024</time> </p> </div> </li> <li role="menuitem" class="lcds-description-list__item"> <div> <h2 class="lcds-description-list__item-heading">Regulated Product(s)</h2> <ul role="menu" class="lcds-metadata-list"> <li role="menuitem">Biologics</li> </ul> </div> </li> </ul> </aside> </div> 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