YERVOY (ipilimumab), monoclonal antibody
Reason for request
Insufficient clinical benefit to justify reimbursement in the treatment of adolescents (12 to 17 years) with advanced melanoma due to the absence of role in the therapeutic strategy
YERVOY monotherapy has MA in the treatment of adolescent patients age 12 years and over with advanced (non-resectable or metastatic melanoma).
Its clinical benefit is insufficient in treatment-naive or pretreated adolescents (age 12 to 17 inclusive), in light of, in particular, efficacy and safety data especially limited in adolescents, the superiority of anti-PD1 (nivolumab, pembrolizumab) demonstrated compared to ipilimumab in treatment-naive adults and the absence of efficacy or safety data in adults after failure of standard treatments (anti-PD1 or anti-B-RAF/anti-MEK).
YERVOY has no role in the current therapeutic strategy for advanced melanoma in adolescents.
Clinical Added Value