Inclusion on the list of medicines refundable by National Health Insurance and approved for hospital use.
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Clinical Benefit
Substantial
the actual benefit of ZELBORAF in the treatment of adult patients with BRAF V600 mutation-positive unresectable or metastatic melanoma is substantial.
Clinical Added Value
moderate
Taking into account : - an improvement in median overall survival and progression-free survival, - a safety profile highlighting in particular an increased risk of a second primary skin cancer, - the targeted nature of the medicinal product, the Transparency Committee considers that, in the current state of the dossier, ZELBORAF provides a moderate improvement in actual benefit (IAB level III) in the treatment of BRAF V600 mutation-positive unresectable or metastatic melanoma.
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