EMEA-002335-PIP01-18 - paediatric investigation plan

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

Key facts

• Active substance:
  autologous T cells transduced with retroviral vector encoding an anti-CD19 CD28/CD3-zeta chimeric antigen receptor (axicabtagene ciloleucel)
• Therapeutic area:
  Oncology
• Decision number:
  P/0232/2018
• PIP number:
  EMEA-002335-PIP01-18
• Pharmaceutical form(s):
  Suspension for injection
• Condition(s) / indication(s):
  Treatment of mantle cell lymphoma
• Route(s) of administration:
  Intravenous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  15/08/2018
• Compliance check done:
  No

Decision

P/0232/2018: EMA decision of 15 August 2018 on the granting of a product specific waiver for autologous T cells transduced with retroviral vector encoding an anti-CD19 CD28/CD3- zeta chimeric antigen receptor (EMEA-002335-PIP01-18)

Reference Number: EMA/480847/2018