EMEA-003516-PIP01-23 - paediatric investigation plan

IIgG-like T cell engager binding to DLL3 and CD3

Key facts

• Active Substance:
  IIgG-like T cell engager binding to DLL3 and CD3
• Therapeutic area:
  Neoplasms benign, malignant and unspecified (incl cysts and polyps)
• Decision number:
  P/0048/2024
• PIP number:
  EMEA-003516-PIP01-23
• Pharmaceutical form(s):
  Solution for infusion
• Condition(s) / indication(s):
  • Treatment of neuroendocrine carcinoma (excluding neuroblastoma)
  • Treatment of small cell lung carcinoma
• Route(s) of administration:
  Parenteral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  08/03/2024

Decision

P/0048/2024 : EMA decision of 8 March 2024 on the granting of a product-specific waiver for IgG-like T cell engager binding to DLL3 and CD3 (EMEA-003516-PIP01-23)

AdoptedReference Number: EMA/50883/2024