AGC Biologics to Manufacture LVV for CAR-T Therapy Approved by FDA for Autolus Therapeutics’ AUCATZYL®

Dec. 11, 2024 — Today, we announced that the U.S. Food and Drug Administration (FDA) approved our Milan Cell and Gene Center of Excellence site for commercial manufacturing of lentiviral vectors for Autolus Therapeutics’ AUCATZYL® (obecabtagene autoleucel – obe-cel). The T-Cell therapy treatment is approved for adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL); AUCATZYL received approval from the FDA on November 8, 2024. AUCATZYL is the first CAR-T therapy approved by the FDA with no requirement for Risk Evaluation Mitigation Strategy (REMS) programming. Please see full Prescribing Information, including BOXED WARNING and Medication Guide.

This achievement follows the Milan site receiving FDA approval in March to manufacture a hematopoietic stem cell (HSC) gene therapy from Orchard Therapeutics. AGC Biologics’ Cell and Gene Center of Excellence has one of the strongest track records in the industry, having supported the production of 30 percent of all ex-vivo gene therapies commercially approved on the market today, and producing 5 commercial viral vectors used for ex-vivo gene therapy.

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