EMEA-003471-PIP01-23 - paediatric investigation plan

humanised IgG1 monoclonal antibody against integrin beta-6 conjugated to monomethyl auristatin E via a valine-citrulline linker (SGN-B6A)

Key facts

• Active Substance:
  humanised IgG1 monoclonal antibody against integrin beta-6 conjugated to monomethyl auristatin E via a valine-citrulline linker (SGN-B6A)
• Therapeutic area:
  Neoplasms benign, malignant and unspecified (incl cysts and polyps)
• Decision number:
  P/0475/2023
• PIP number:
  EMEA-003471-PIP01-23
• Pharmaceutical form(s):
  All pharmaceutical forms
• Condition(s) / indication(s):
  Treatment of non-small cell lung cancer
• 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:
  01/12/2023

Decision

P/0475/2023 : EMA decision of 1 Dec 2023 on the granting of a product specific waiver for humanised IgG1 monoclonal antibody against integrin beta-6 conjugated to monomethyl auristatin E via a valine-citrulline linker (SGN B6A) (EMEA-003471-PIP01-23)

Reference Number: EMA/498422/2023