EMA/PE/0000253350 - paediatric investigation plan

humanised IgG1 monoclonal antibody against B7H4 receptor conjugated to N-((2R,10S)-10-benzyl-2-cyclopropyl-1-(((1S,9S)-9-ethyl-5-fluoro-9-hydroxy-4-methyl-10,13-dioxo-2,3,9,10,13,15-hexahydro-1H,12H-benzo[de]pyrano[3',4':6,7]indolizino[1,2-b]quinolin-1-yl)amino)-1,6,9,12,15-pentaoxo-3-oxa-5,8,11,14-tetraazahexadecan-16-yl)-6-(2,5-dioxo-2,5-dihydro-1H-pyrrol-1-yl)hexanamide

Key facts

• Active substance:
  humanised IgG1 monoclonal antibody against B7H4 receptor conjugated to N-((2R,10S)-10-benzyl-2-cyclopropyl-1-(((1S,9S)-9-ethyl-5-fluoro-9-hydroxy-4-methyl-10,13-dioxo-2,3,9,10,13,15-hexahydro-1H,12H-benzo[de]pyrano[3',4':6,7]indolizino[1,2-b]quinolin-1-yl)amino)-1,6,9,12,15-pentaoxo-3-oxa-5,8,11,14-tetraazahexadecan-16-yl)-6-(2,5-dioxo-2,5-dihydro-1H-pyrrol-1-yl)hexanamide
• Therapeutic area:
  Neoplasms benign, malignant and unspecified (incl cysts and polyps)
• Decision number:
  EMA/PE/0000253350
• PIP number:
  EMA/PE/0000253350
• Pharmaceutical form(s):
  All pharmaceutical forms
• Condition(s) / indication(s):
  • Adjunctive treatment in haematopoietic stem cell transplantation
  • Treatment of fallopian tube cancer
  • Treatment of ovarian cancer
  • Treatment of primary peritoneal 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:
  11/07/2025
• Compliance check done:
  Nej

Decision

EMA/PE/0000253350: EMA decision of 11 July 2025 on the granting of a product specific waiver for humanised IgG1 monoclonal antibody against B7H4 receptor conjugated to N-((2R,10S)-10-benzyl-2-cyclopropyl-1-(((1S,9S)-9-ethyl-5-fluoro-9-hydroxy- 4-methyl...

Adopted Reference Number: EMADOC-1700519818-2240566