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...

歐洲委員會已批准諾華的Kisqali（利博西里）與芳香化酶抑制劑聯合用於輔助治療激素受體陽性、人類表皮生長因子受體2陰性的早期乳腺癌高風險...

Benzinga · 2024/11/27 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.

審批基於第三階段NATALEE數據，顯示Kisqali（利泊昔布）加輔助內分泌治療（ET）在II期或III期HR+/HER2-早期乳腺癌（EBC）患者中顯示出臨床意義的侵襲性無病生存期（iDFS）獲益，並在所有亞組中一致。
憑藉這一廣泛的適應症，歐洲幾乎兩倍的EBC患者，包括那些淋巴結陰性疾病的患者，現在可以接受Kisqali治療，以幫助降低復發風險。
儘管接受ET治療，超過三分之一被診斷爲II期和III期EBC的人仍會在長期內經歷癌症復發，常常表現爲無法治癒的愛文思控股疾病。
最近呈現的NATALEE試驗的四年分析顯示，在三年治療期結束後，iDFS獲益持續加深。

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