Novartis AG (NVS) Thursday announced that the FDA has granted Breakthrough Therapy designation to Scemblix for treating adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia or CML in chronic phase. This is the third Breakthrough Therapy designation assigned to Scemblix.

诺华公司（NVS）周四宣布，美国食品和药物管理局（FDA）已授予Scemblix突破性治疗指定，用于治疗新诊断的费城染色体阳性慢性粒细胞白血病（CML）慢性期成年患者。这是分配给Scemblix的第三个突破性治疗名称。

The designation is based on positive data from the Phase III ASC4FIRST study, in which Scemblix met both primary endpoints, compared to imatinib alone. In comparison with standard-of-care drugs, Scemblix demonstrated a favorable safety and tolerability profile.Breakthrough Therapy designation is usually to a drug compound that targets a serious or life-threatening disease and demonstrates a potential substantial improvement over existing therapies..

该名称基于III期ASC4FIRST研究的阳性数据，与单独使用伊马替尼相比，Scemblix符合两个主要终点。与标准护理药物相比，Scemblix表现出良好的安全性和耐受性。突破性治疗指定通常是针对严重或危及生命的疾病的药物化合物，并显示出比现有疗法潜在的实质性改进。。

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