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OPDIVO (nivolumab), anti-PD1 antibody
ONCOLOGY - New indication
Opinions on drugs -
Posted on
Jul 19 2018
Reason for request
Extension of indication
Clinical benefit of the OPDIVO + YERVOY combination:
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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;
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insufficient in other cases for publicly funded care
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OPDIVO in combination with ipilimumab has been granted a marketing authorisation for the treatment of adults with advanced (non-resectable or metastatic) melanoma.
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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
| Substantial |
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| Insufficient |
Clinical Added Value
| no clinical added value |
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