欧盟可以以更好的答复率和安全性为由,批准诺瓦尔蒂斯的CML Scemblix。 The EU may approve Novartis’ Scemblix for CML, citing better response rates and safety.

欧洲医药署(ECMP)建议批准诺瓦尔蒂斯(Novartis)Scemblix(Asciminib)为新诊断和以前治疗过费城染色体阳性慢性短血细胞白血病的成年人提供长期治疗。 The European Medicines Agency’s CHMP has recommended approval of Novartis’ Scemblix (asciminib) for adults with newly diagnosed and previously treated Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase. 该决定基于第三阶段试验数据,表明Scemblix与目前的一线疗法相比,主要分子反应率较高,安全性更高。 The decision, based on Phase III trial data, shows Scemblix achieved higher major molecular response rates and better safety compared to current first-line therapies. 如果欧洲委员会批准(预期在两个月内),Scemblix可成为欧洲新的护理标准,提供一种成熟的治疗选择,有可能改善长期效果。 If approved by the European Commission, expected within two months, Scemblix could become a new standard of care in Europe, offering a well-tolerated treatment option with potential for improved long-term outcomes.