FDA Approved Products

SSM Cardinal Glennon Children's Medical Center 04/24/2019 Biologics Gene Therapy
1- BREYANZI: For treatment of adult patients with large B-cell lymphoma (LBCL),
including diffuse large B-cell lymphoma (DLBCL) not otherwise specified
(including DLBCL arising from indolent lymphoma), high-grade B-cell
lymphoma, primary mediastinal large B-cell lymphoma, and follicular
lymphoma grade 3B, who have:
Refractory disease to first-line chemoimmunotherapy or relapse within 12
months of first-line chemoimmunotherapy; or
Refractory disease to first-line chemoimmunotherapy or relapse after first-line
chemoimmunotherapy and are not eligible for hematopoietic stem cell
transplantation (HSCT) due to comorbidities or age; or
Relapsed or refractory disease after two or more lines of systemic therapy.
Limitations of Use: BREYANZI is not indicated for the treatment of patients with
primary central nervous system lymphoma
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company 07/01/2022
2- CARVYKTI (ciltacabtagene autoleucel): Treatment of adult patients with
relapsed or refractory multiple myeloma after four or more prior lines of
therapy, including a proteasome inhibitor, an immunomodulatory agent, and
an anti-CD38 monoclonal antibody.
Janssen Biotech, Inc. 05/18/2023 Biologics Gene Therapy
3- CLEVECORD (HPC Cord Blood): For use in unrelated donor hematopoietic
progenitor cell transplantation procedures in conjunction with an appropriate
preparative regimen for hematopoietic and immunologic reconstitution in
patients with disorders affecting the hematopoietic system that are inherited,
acquired, or result from myeloablative treatment.
Cleveland Cord Blood Center 10/03/2019 Biologics Gene Therapy
4- Ducord, HPC Cord Blood: For use in unrelated donor hematopoietic progenitor
cell transplantation procedures in conjunction with an appropriate preparative
regimen for hematopoietic and immunologic reconstitution in patients with
disorders affecting the hematopoietic system that are inherited, acquired, or
result from myeloablative treatment.
Duke University School of Medicine 04/24/2019 Biologics Gene Therapy
5- ELEVIDYS: For the Treatment of ambulatory pediatric patients aged 4 through
5 years with Duchenne muscular dystrophy (DMD) with a confirmed mutation
in the DMD gene.
delandistrogene moxeparvovec (catalent) 07/13/2023 Biologics

1
 6- GINTUIT (Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine
Collagen): Is an allogeneic cellularized scaffold product indicated for topical
(non-submerged) application to a surgically created vascular wound bed in the
treatment of mucogingival conditions in adults.
Organogenesis Incorporated 02/20/2018 Biologics Gene Therapy
7- HEMACORD (HPC, cord blood): For use in unrelated donor hematopoietic
progenitor cell transplantation procedures in conjunction with an appropriate
preparative regimen for hematopoietic and immunologic reconstitution in
patients with disorders affecting the hematopoietic system that are inherited,
acquired, or result from myeloablative treatment.
New York Blood Center 04/24/2019 Biologics Gene Therapy
8- HEMGENIX: is an adeno-associated virus vector-based gene therapy indicated
for the treatment of adults with Hemophilia B (congenital Factor IX deficiency)
who:
•Currently use Factor IX prophylaxis therapy, or
•Have current or historical life-threatening hemorrhage, or
•Have repeated, serious spontaneous bleeding episodes.
CSL Behring LLC 01/04/2023
9- HPC, Cord Blood: For use in unrelated donor hematopoietic progenitor cell
transplantation procedures in conjunction with an appropriate preparative
regimen for hematopoietic and immunologic reconstitution in patients with
disorders affecting the hematopoietic system that are inherited, acquired, or
result from myeloablative treatment.
Clinimmune Labs, University of Colorado Cord Blood Bank 04/24/2019 Biologics Gene
Therapy
10- HPC, Cord Blood - MD Anderson Cord Blood Bank: For use in unrelated donor
hematopoietic progenitor cell transplantation procedures in conjunction with
an appropriate preparative regimen for hematopoietic and immunologic
reconstitution in patients with disorders affecting the hematopoietic system
that are inherited, acquired, or result from myeloablative treatment.
MD Anderson Cord Blood Bank 04/24/2019 Biologics Gene Therapy
11- HPC, Cord Blood – LifeSouth: For use in unrelated donor hematopoietic
progenitor cell transplantation procedures in conjunction with an appropriate
preparative regimen for hematopoietic and immunologic reconstitution in
patients with disorders affecting the hematopoietic system that are inherited,
acquired, or result from myeloablative treatment.
LifeSouth Community Blood Centers, Inc. 07/27/2023 Biologics Gene Therapy

2
 12- HPC, Cord Blood – Bloodworks: For use in unrelated donor hematopoietic
progenitor cell transplantation procedures in conjunction with an appropriate
preparative regimen for hematopoietic and immunologic reconstitution in
patients with disorders affecting the hematopoietic system that are inherited,
acquired, or result from myeloablative treatment.
Bloodworks 10/04/2019 Biologics Gene Therapy
13- IMLYGIC (talimogene laherparepvec): For the local treatment of unresectable
cutaneous, subcutaneous, and nodal lesions in patients with melanoma
recurrent after initial surgery.
BioVex, Inc., a subsidiary of Amgen Inc. 02/15/2023 Biologics Gene Therapy
14- KYMRIAH (tisagenlecleucel): KYMRIAH is a CD19-directed genetically modified
autologous T cell immunotherapy indicated for the treatment of adult patients
with relapsed or refractory follicular lymphoma after two or more lines of
therapy
Novartis Pharmaceuticals Corporation 07/07/2022 Biologics Gene Therapy
15- LANTIDRA (donislecel): the treatment of adults with Type 1 diabetes who are
unable to approach target HbA1c because of current repeated episodes of
severe hypoglycemia despite intensive diabetes management and education.
CellTrans Inc. 08/07/2023 Biologics
16- LAVIV (Azficel-T): Indicated for improvement of the appearance of moderate
to severe nasolabial fold wrinkles in adults.
Fibrocell Technologies 03/16/2018 Biologics Gene Therapy
17- LUXTURNA: For the treatment of patients with confirmed biallelic RPE65
mutation-associated retinal dystrophy.
Spark Therapeutics, Inc. 06/09/2022 Biologics Gene Therapy
18- MACI (Autologous Cultured Chondrocytes on a Porcine Collagen Membrane):
Indicated for the repair of single or multiple symptomatic, full-thickness
cartilage defects of the knee with or without bone involvement in adults. MACI
is an autologous cellularized scaffold product.
Vericel Corp. 06/30/2021 Biologics Gene Therapy
19- OMISIRGE (omidubicel-onlv): For use in adults and pediatric patients 12 years
and older with hematologic malignancies who are planned for umbilical cord
blood transplantation following myeloablative conditioning to reduce the time
to neutrophil recovery and the incidence of infection.
Gamida Cell Ltd. 05/16/2023 Biologics

3
 20- PROVENGE (sipuleucel-T): For the treatment of asymptomatic or minimally
symptomatic metastatic castrate resistant (hormone refractory) prostate
cancer.
Dendreon Corp. 05/28/2019 Biologics Gene Therapy
21- RETHYMIC: For immune reconstitution in pediatric patients with congenital
athymia.
Enzyvant Therapeutics GmbH 11/04/2021
22- ROCTAVIAN (valoctocogene roxaparvovec-rvox): Indicated for the treatment
of adults with severe hemophilia A (congenital factor VIII deficiency with factor
VIII activity <1 IU/dL) without pre-existing antibodies to adeno-associated virus
serotype 5 detected by an FDA-approved test.
23- YESCARTA (axicabtagene ciloleucel): For the treatment of adult patients with
large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or
that relapses within 12 months of first-line chemoimmunotherapy.
Axicabtagene ciloleucel is not indicated for the treatment of patients with
primary central nervous system lymphoma.
Kite Pharma, Incorporated 11/04/2022 Gene Therapy
24- ZYNTEGLO (betibeglogene autotemcel): For treatment of adult and pediatric
patients with ß-thalassemia who require regular red blood cell (RBC)
transfusions
bluebird bio, Inc. 09/19/2022
25- ZOLGENSMA (onasemnogene abeparvovec-xioi): For the treatment of
pediatric patients less than 2 years of age with spinal muscular atrophy (SMA)
with bi allelic mutations in the survival motor neuron 1 (SMN1) gene.
Novartis Gene Therapies, Inc. 10/18/2023