欧州医薬品庁(EMA)の医薬品委員会(CHMP)が、BRAF V600変異陽性の皮膚悪性腫瘍に対する術後治療としてのBRAF阻害薬ダブラフェニブ+MEK阻害薬トラメチニブの承認について肯定的見解【スイス・NOVARTIS】

Novartis combination Tafinlar® + Mekinist® receives positive CHMP opinion for adjuvant treatment of BRAF V600 mutation-positive melanoma

Basel, July 27, 2018 – Novartis today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of Tafinlar® (dabrafenib) in combination with Mekinist® (trametinib) for the adjuvant treatment of adult patients with stage III melanoma with a BRAF V600 mutation, following complete resection. The CHMP recommendation is based on findings from the COMBI-AD study, which was published in The New England Journal of Medicine (NEJM).


 


 


 

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