EMEA-003543-PIP01-23 - paediatric investigation plan

autologous T-cells expressing a chimeric antigenic receptor against G protein coupled receptor class C, group 5, member D (GPRC5D) (BMS-986393)

Key facts

• Active Substance:
  autologous T-cells expressing a chimeric antigenic receptor against G protein coupled receptor class C, group 5, member D (GPRC5D) (BMS-986393)
• Therapeutic area:
  Neoplasms benign, malignant and unspecified (incl cysts and polyps)
• Decision number:
  P/0128/2024
• PIP number:
  EMEA-003543-PIP01-23
• 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:
  12/04/2025

Decision

P/0128/2024: EMA decision of 12 April 2024 on the granting of a product specific waiver for autologous T-cells expressing a chimeric antigenic receptor against G protein coupled receptor class C, group 5, member D (GPRC5D)... (EMEA-003543-PIP01-23)

AdoptedReference Number: EMA/114622/2024