Reason for request


Key points

Favourable opinion for maintenance of reimbursement as monotherapy for the adjuvant treatment of adults with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.

What therapeutic improvement?

Therapeutic improvement in the management of the condition.

Role in the care pathway?

According to the French and European guidelines, in the context of the adjuvant treatment of melanoma with high risk of recurrence:

  • Patients with stage III A, B, C, D and stage IV disease after complete resection of their metastases are eligible for adjuvant treatment; 
  • Interferon and ipilimumab are not recommended as adjuvant treatment;
  • Patients with stage III A, B, C or D, BRAF V600 mutation-positive disease are eligible for treatment with the dabrafenib/trametinib combination or immunotherapy (nivolumab or pembrolizumab). In the absence of comparative studies of these two strategies, there is no data enabling recommendation of one treatment over the other;
  • For patients with stage III A, B, C or D disease with no BRAF V600 mutation, there are no arguments relative to the risk-benefit ratio for recommending one anti-PD-1 (nivolumab versus pembrolizumab) over another.
  • For patients with stage IV disease, OPDIVO (nivolumab) is the only treatment with an MA in this situation.

Role of the medicinal product in the care pathway

OPDIVO (nivolumab) is a first-line adjuvant treatment for adults with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.

In the absence of direct comparative data, its role relative to the alternatives, (pembrozilumab, and the dabrafenib/trametinib combination in BRAF V600 mutation-positive disease) cannot be specified.


Clinical Benefit


The Committee deems that the clinical benefit of OPDIVO (nivolumab) remains substantial in the MA indication.

Clinical Added Value



  • demonstration of the superiority of OPDIVO (nivolumab), as monotherapy, compared to an active treatment (ipilimumab, which has an MA as adjuvant therapy in the USA) on recurrence-free survival (HR= 0.65; CI97.56% [0.51; 0.83] in the primary analysis), in a phase 3 randomised, double-blind study;
  • follow-up data confirming this improvement in terms of recurrence-free survival, an endpoint judged to be relevant in the context of adjuvant therapy for melanoma;

and despite:

  • the absence of demonstration of an improvement in overall survival versus an active treatment (ipilimumab) in the final analysis, but taking into account indirect comparative data suggesting an improvement versus placebo;
  • the absence of any formal conclusion that can be drawn based on the quality-of-life results;

the Transparency Committee considers that OPDIVO (nivolumab), as monotherapy, provides a moderate clinical added value (CAV III) compared to no therapy, in the same way as KEYTRUDA (pembrolizumab), and the MEKINIST/TAFINLAR (dabrafenib, trametinib) combination for patients with a BRAF V600 mutation.

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