ZELBORAF

the actual benefit of ZELBORAF in the treatment of adult patients with BRAF V600 mutation-positive unresectable or metastatic melanoma is substantial.

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.