欧洲医药署的CHMP建议诺瓦尔蒂斯的Kisqali根据NATALEE试验数据进行高风险早期乳癌辅助治疗。 European Medicines Agency's CHMP recommends Novartis' Kisqali for high-risk early breast cancer adjuvant treatment based on NATALEE trial data.
诺华氏乳癌药物Kisqali(ribociclib)得到了欧洲医药署的CHMP的赞成意见,认为该药物可用作成人的辅助治疗,其荷尔蒙受体阳性、HER2-阴性早期乳腺癌极易复发。 Novartis' breast cancer drug Kisqali (ribociclib) has received a favorable opinion from the European Medicines Agency's CHMP for use as an adjuvant treatment in adults with hormone receptor-positive, HER2-negative early breast cancer at high risk of recurrence. 这项建议基于第三阶段NATALEE试验数据,表明复发风险减少了25%。 This recommendation is based on Phase III NATALEE trial data, indicating a 25% reduction in recurrence risk. 预计欧洲联盟委员会将在大约两个月内作出最后决定。 The European Commission's final decision is expected in about two months.