EMEA-003593-PIP02-24 - paediatric investigation plan

autologous CD3-positive T cells transduced with a retroviral vector containing an anti-B cell maturation agent chimeric antigen receptor gene

Key facts

• Active substance:
  autologous CD3-positive T cells transduced with a retroviral vector containing an anti-B cell maturation agent chimeric antigen receptor gene
• Therapeutic area:
  Neoplasms benign, malignant and unspecified (incl cysts and polyps)
• Decision number:
  P/0234/2024
• PIP number:
  EMEA-003593-PIP02-24
• Pharmaceutical form(s):
  All pharmaceutical forms
• Condition(s) / indication(s):
  Treatment of Multiple Myeloma
• Route(s) of administration:
  All routes of administration
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  18/07/2024
• Compliance check done:
  No

Decision

P/0234/2024: EMA decision of 18 July 2024 on the granting of a product specific waiver for autologous CD3-positive T cells transduced with a retroviral vector containing an anti-B cell maturation agent chimeric antigen receptor gene (EMEA-003593-PIP02-24)

Adopted Reference Number: EMA/320747/2024