EMA
approval
· 2026-03-12
EMA Authorised: Tecartus (autologous peripheral blood T cells CD4 and CD8 selected and CD3 and CD28 activated transduced with retroviral vector expressing anti-CD19 CD28/CD3-zeta chimeric antigen receptor and cultured (brexucabtagene autoleucel)) — Kite Pharma EU B.V.
Summary
The European Medicines Agency authorised Tecartus (brexucabtagene autoleucel) for mantle cell lymphoma with conditional approval, and it has orphan designation.
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Diseases / indications
Drugs mentioned
Snippet
Status: Authorised. Therapeutic area: Lymphoma, Mantle-Cell. MAH: Kite Pharma EU B.V.. Decision date: 26/02/2026. Conditional approval. Orphan medicine