EMEA-001862-PIP01-15-M03 - paediatric investigation plan

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 (KTE-X19)
PIPHuman

Key facts

Invented name
Tecartus
Active Substance
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 (KTE-X19)
Therapeutic area
Oncology
Decision number
P/0377/2023
PIP number
EMEA-001862-PIP01-15-M03
Pharmaceutical form(s)
Dispersion for injection
Condition(s) / indication(s)
Treatment of acute lymphoblastic leukaemia
Route(s) of administration
Intravenous use
Contact for public enquiries

Kite Pharma EU B.V.

Tel. +1 4242091332
E-mail: regulatory@kitepharma.com

Decision type
PM: decision on the application for modification of an agreed PIP
Decision date

Decision

P/0377/2023: EMA decision of 8 September 2023 on the acceptance of a modification of an agreed paediatric investigation plan for brexucabtagene autoleucel (Tecartus), (EMEA-001862-PIP01-15-M03)

Reference Number: EMA/351212/2023

English (EN) (209.69 KB - PDF)

First published:
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