Source: FDA, National Drug Code (US) Revision Year: 2024
AMTAGVI (lifileucel) is a tumor-derived autologous T cell immunotherapy comprised of a suspension of tumor-derived T cells for intravenous infusion. AMTAGVI is manufactured from resected patient tumor tissue prosected from one or more tumor lesions. Immune cells derived from a patient’s tumor(s) are expanded in cell culture, washed, formulated as a cell suspension, and cryopreserved. The product must pass a sterility test before release for shipping as a frozen suspension in 1 to 4 patient-specific infusion bag(s) in individual protective metal cassettes. The product is thawed prior to administration back into the same patient [see Dosage and Administration (2.2), How Supplied/Storage and Handling (16)].
AMTAGVI is composed primarily of T cells of the CD4+T and CD8+T cell lineages. AMTAGVI may also contain monocytes and other lymphocytes, including B cells and NK cells. AMTAGVI may contain viable melanoma tumor cells from the original tumor tissue used to manufacture the product.
The formulation contains 48% PlasmaLyte A, 50% CryoStor CS10 (resulting in final concentration of 5% dimethyl sulfoxide (DMSO)), 2% of 25% human serum albumin (resulting in a final concentration of 0.5% albumin), and 300 IU/mL IL-2 (aldesleukin).
A single dose of AMTAGVI is provided in 1 to 4 infusion bag(s) containing 100 mL to 125 mL of viable cells per bag in individual protective cassettes.
| Dosage Forms and Strengths |
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AMTAGVI is a cell suspension for intravenous infusion. A single dose of AMTAGVI contains 7.5 × 109 to 72 × 109 viable cells suspended in a cryopreservation medium. A single dose is split into 1 to 4 patient-specific infusion bag(s) (100 mL to 125 mL per bag) in individual protective metal cassettes [see How Supplied/Storage and Handling (16)]. |
| How Supplied |
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AMTAGVI is supplied in 1 to 4 infusion bag(s) (NDC 73776-001-11), with each bag containing approximately 100 mL to 125 mL of frozen suspension of tumor-derived T cells in 5% DMSO, 0.5% albumin (human), and 300 IU/mL IL-2 (aldesleukin). Each bag is contained within a protective metal cassette (NDC 73776-001-12). AMTAGVI is stored in the vapor phase of liquid nitrogen and supplied in a liquid nitrogen cryoshipper. Manufactured by: WuXi Advanced Therapeutics, Inc., 4000 South 26th Street, Philadelphia, PA 19112 OR Iovance Biotherapeutics Manufacturing LLC, 300 Rouse Boulevard, Philadelphia, PA 19112 Marketed by: Iovance Biotherapeutics Manufacturing LLC, 300 Rouse Boulevard, Philadelphia, PA 19112 |
| Drug | Countries | |
|---|---|---|
| AMTAGVI | United States |
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