EMEA-002585-PIP01-19 - paediatric investigation plan

autologous human T cells genetically modified ex-vivo with a lentiviral vector encoding a chimeric antigen receptor (CAR) for B-cell maturation antigen (BCMA) (JNJ-68284528)

Key facts

• Active substance:
  autologous human T cells genetically modified ex-vivo with a lentiviral vector encoding a chimeric antigen receptor (CAR) for B-cell maturation antigen (BCMA) (JNJ-68284528)
• Therapeutic area:
  Oncology
• Decision number:
  P/0353/2019
• PIP number:
  EMEA-002585-PIP01-19
• Pharmaceutical form(s):
  Dispersion for infusion
• Condition(s) / indication(s):
  Treatment of Multiple Myeloma
• Route(s) of administration:
  Intravenous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  04/10/2019
• Compliance check done:
  No

Decision

P/0353/2019: EMA decision of 4 October 2019 on the granting of a product specific waiver for autologous human T cells genetically modified ex-vivo with a lentiviral vector encoding a chimeric antigen receptor (CAR) for B-cell maturation antigen (BCMA) (JN

Adopted Reference Number: EMA/526955/2019