Orphan Designations for CAR-T Medicinal Products in Europe

Orphan Designation Number

Date

Active Substance

Disease/Condition

EU/3/20/2252

28/2/2020

Autologous human T cells genetically modified ex-vivo with a lentiviral vector encoding a chimeric antigen receptor for B-cell maturation antigen

Treatment of multiple myeloma

EU/3/19/2220

13/11/2019

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

Treatment of mantle cell lymphoma

EU/3/18/2018

25/5/2018

Autologous CD4+ and CD8+ T cells expressing a CD19-specific chimeric antigen receptor

Treatment of follicular lymphoma

EU/3/17/1890

17/7/2017

Treatment of diffuse large B-cell lymphoma

EU/3/17/1863

20/4/2017

Autologous T lymphocyte-enriched population of cells transduced with a lentiviral vector encoding a chimeric antigen receptor targeting human B cell maturation antigen with 4-1BB and CD3-zeta intracellular signalling domains

Treatment of multiple myeloma

EU/3/17/1833

27/2/2017

Autologous T-cells transduced with lentiviral vector encoding an anti-SLAMF7 CD28/CD3-zeta chimeric antigen receptor

Treatment of plasma cell myeloma

EU/3/16/1745

14/10/2016

Autologous T cells transduced with lentiviral vector containing a chimeric antigen receptor directed against CD19 (tisagenlecleucel)

Treatment of diffuse large B-cell lymphoma

EU/3/15/1571

11/11/2015

Autologous T cells transduced with retroviral vector encoding an anti-CD19 CD28/CD3-zeta chimeric antigen receptor

 

Treatment of acute lymphoblastic leukaemia

EU/3/15/1579

11/11/2015

Treatment of follicular lymphoma

EU/3/15/1552

09/10/2015

Treatment of mantle cell lymphoma

EU/3/15/1553

09/10/2015

Autologous T cells transduced with retroviral vector encoding an anti-CD19 CD28/CD3-zeta chimeric antigen receptor (axicabtagene ciloleucel)

Treatment of primary mediastinal large B-cell lymphoma

EU/3/14/1393

16/12/2014

Treatment of diffuse large B-cell lymphoma

EU/3/14/1266

29/4/2014

Autologous T cells transduced with lentiviral vector containing a chimeric antigen receptor directed against CD19 (tisagenlecleucel)

Treatment of B-lymphoblastic leukaemia/lymphoma

Last Updated on Thursday 27 August 2020.