The European Commission Has Approved Novartis' Kisqali (Ribociclib) In Combination With An Aromatase Inhibitor For The Adjuvant Treatment Of Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Early Breast Cancer At High Risk...

欧洲委员会已批准诺华的Kisqali（利博西尼）与芳香化酶抑制剂联合用于辅助治疗激素受体阳性、人类表皮生长因子受体2阴性的早期乳腺癌，病情处于高危状态...

Benzinga · 11/27 18:09

The European Commission Has Approved Novartis' Kisqali (Ribociclib) In Combination With An Aromatase Inhibitor For The Adjuvant Treatment Of Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Early Breast Cancer At High Risk Of Recurrence

Approval is based on Phase III NATALEE data showing Kisqali (ribociclib) plus adjuvant endocrine therapy (ET) demonstrated clinically meaningful invasive disease-free survival (iDFS) benefit in patients with stage II or III HR+/HER2- early breast cancer (EBC), consistent across all subgroups.
With this broad indication, nearly twice as many EBC patients in Europe, including those with node-negative disease, could now be eligible for treatment with Kisqali to help reduce their risk of recurrence.
Despite ET, more than one-third of people diagnosed with stage II and III EBC will experience a return of their cancer in the long term, often as incurable advanced disease.
Recently presented four-year analysis of the ongoing NATALEE trial showed a deepening iDFS benefit after completion of three-year treatment period.

审批基于第三阶段NATALEE数据，显示Kisqali（利泊昔布）加辅助内分泌治疗（ET）在II期或III期HR+/HER2-早期乳腺癌（EBC）患者中显示出临床意义的侵袭性无病生存期（iDFS）获益，并在所有亚组中一致。
凭借这一广泛的适应症，欧洲几乎两倍的EBC患者，包括那些淋巴结阴性疾病的患者，现在可以接受Kisqali治疗，以帮助降低复发风险。
尽管接受ET治疗，超过三分之一被诊断为II期和III期EBC的人仍会在长期内经历癌症复发，常常表现为无法治愈的爱文思控股疾病。
最近呈现的NATALEE试验的四年分析显示，在三年治疗期结束后，iDFS获益持续加深。

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