Reason for request

Extension of indication

Clinical benefit of the OPDIVO + YERVOY combination:

  • high for the treatment of advanced melanoma only as a first-line treatment for patients with ECOG 0 - 1, with non-B-RAF-mutated tumour, not presenting with active brain metastasis and administered in centres equipped with an interdisciplinary medical resuscitation unit or equivalent but no clinical added value in patient care;

  • insufficient in other cases for publicly funded care


  • OPDIVO in combination with ipilimumab has been granted a marketing authorisation for the treatment of adults with advanced (non-resectable or metastatic) melanoma.

  • It is a first-line therapeutic option, which can only be offered in the context of a multidisciplinary review meeting to a selected population: advanced-stage melanoma, ECOG 0 or 1, with non-B-RAF-mutated tumour in the absence of active brain metastasis.





Clinical Benefit




Clinical Added Value

no clinical added value


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