诺华(NVS.US)重磅小分子药物再获欧盟委员会批准 有望变革早期乳腺癌治疗

智通财经
Nov 28, 2024

智通财经APP获悉,诺华(NVS.US)(Novartis)公司今天宣布,欧盟委员会(EC)已批准CDK4/6抑制剂Kisqali(ribociclib)联合芳香酶抑制剂(AI),作为辅助疗法,治疗激素受体(HR)阳性、人表皮生长因子受体2(HER2)阴性的高复发风险早期乳腺癌(EBC)患者。

这一批准基于关键性3期临床试验NATALEE的结果,该试验涵盖了广泛的患者群体,包括HR+/HER2-的II期和III期早期乳腺癌患者,其中也包括无淋巴结转移的患者。试验结果显示,与单纯的内分泌治疗(ET)相比,Kisqali联合内分泌治疗可显著且具有临床意义地将疾病复发风险降低25.1%(HR=0.749;95% CI:0.628,0.892;P=0.0006)。在所有患者亚组中均一致观察到侵袭性无病生存期(iDFS)的改善。

最近在2024年欧洲肿瘤内科学会(ESMO)大会上发布的NATALEE试验的最新分析进一步巩固了FDA审查的数据。结果显示,三年治疗期后患者获益进一步加深,与单独接受ET的患者相比,Kisqali组合疗法组患者复发风险降低了28.5%(HR=0.715;95% CI:0.609,0.840;P<0.0001)。诺华将继续对NATALEE患者进行长期结果的评估,包括总生存期。

Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.

Most Discussed

  1. 1
     
     
     
     
  2. 2
     
     
     
     
  3. 3
     
     
     
     
  4. 4
     
     
     
     
  5. 5
     
     
     
     
  6. 6
     
     
     
     
  7. 7
     
     
     
     
  8. 8
     
     
     
     
  9. 9
     
     
     
     
  10. 10