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Opinions on drugs - Posted on Sep 12 2013

Reason for request

Inclusion on the list of medicines refundable by National Health Insurance and approved for hospital use.


Clinical Benefit


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


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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