Nivolumab (25) – Opdivo®

Young people aged 12 years and over with melanoma involving lymph nodes or with metastases following complete resection; adjuvant treatment

• The additional benefit is not proven.
• For the assessment of the additional benefit of nivolumab for the adjuvant treatment of adolescents aged 12 to 17 years with melanoma involving lymph nodes or with metastases following complete resection, the pharmaceutical manufacturer has not provided any data directly comparing the treatment with the appropriate comparator therapy.
• Furthermore, no clinical trial relevant to the present therapeutic indication could be identified, and therefore no indirect comparison with the appropriate comparator therapy could be carried out.
• Consequently, no data were submitted for the assessment of the additional benefit of nivolumab compared with the appropriate comparator therapy for the adjuvant treatment of melanoma with lymph node involvement or metastasis following complete resection in adolescents aged 12 years and over.
• Overall, no additional benefit compared with the appropriate comparator therapy can be inferred for adolescents aged 12 years and over.
• Summary of the assessment
  • No data were submitted by the pharmaceutical manufacturer that would enable an assessment of the additional benefit.
  • The pharmaceutical manufacturer also deemed it unfeasible to conduct an evidence transfer from the adult population to adolescents aged 12 and over.
  • An additional benefit is therefore not proven.

Courtesy translation only, please refer to the German original.