European Commission Grants Approval for Lentiviral Vector–Based CAR-T Therapy

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The European Commission has granted marketing authorization for AUCATZYL® (obecabtagene autoleucel, obe-cel), a next-generation CAR-T cell therapy developed by Autolus Therapeutics. This approval marks a significant step forward for patients across all 27 EU member states who are in need of innovative treatment options for relapsed or refractory B-cell malignancies.

AUCATZYL® is manufactured using lentiviral vectors produced at AGC Biologics’ facility in Milan, Italy, a site with deep expertise in viral vector development and GMP manufacturing. With this decision, the Milan site now supports its tenth product approved by either the European Medicines Agency (EMA) or the U.S. Food and Drug Administration (FDA), underscoring its reputation as a trusted global partner in cell and gene therapy manufacturing.

Lentiviral vectors remain one of the most reliable tools for gene modification in CAR-T therapy, providing stable integration and sustained expression of therapeutic genes. Their successful application in a newly approved therapy demonstrates how critical vector quality and scalability are to ensuring both safety and efficacy in advanced treatments.

This milestone approval reflects two major trends in the global cell and gene therapy field:

Validation of lentiviral technology as a cornerstone for next-generation CAR-T therapies.

Rising demand for manufacturing excellence, as complex therapies increasingly rely on dependable, GMP-compliant vector production.

For the broader industry, the authorization of AUCATZYL® signals a stronger regulatory and clinical foundation for lentiviral vector–based therapies. It also highlights the strategic importance of building robust supply chains and partnerships that can deliver safe, scalable solutions to meet the growing global demand for cell and gene therapies.

Source: https://www.agcbio.com/news/european-commission-approves-car-t-therapy-with-lentiviral-vectors-manufactured-by-agc-biologics