OPDIVO (nivolumab), anti-PD1 antibody
Reason for request
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 Added Value
|no clinical added value||