Ipilimumab (3) – Yervoy®

• Clinical trials
  • The CA184-178 trial was a single-arm, open-label trial of ipilimumab in adolescents (aged ≥ 12 to < 18 years) with previously treated or untreated advanced (unresectable or metastatic) stage III or IV melanoma.

Young people aged 12 years and over

• The additional benefit is not proven
• For ipilimumab as monotherapy for the treatment of advanced (unresectable or metastatic) melanoma in adolescents aged 12 years and over, additional benefit is not proven compared with the appropriate comparator therapy, ‘treatment at the doctor’s discretion’.
• Given the current state of scientific knowledge and for methodological reasons, it is not appropriate to extrapolate the evidence submitted by the pharmaceutical manufacturer from adults to adolescents.
• Overall assessment / Conclusion
  • For ipilimumab as monotherapy for the treatment of advanced (unresectable or metastatic) melanoma in adolescents aged 12 years and over, an additional benefit is not proven compared with the appropriate comparator therapy, ‘treatment as the doctor deems appropriate’.
  • Given the current state of scientific knowledge and for methodological reasons, it is not appropriate to extrapolate the evidence from adults to adolescents as presented by the pharmaceutical manufacturer.

Courtesy translation only, please refer to the German original.