欧州委員会は、Novartisのキスカリ（リボシクリブ）が、アロマターゼ阻害剤との併用で、ホルモン受容体陽性、ヒト上皮成長因子受容体2陰性の高リスク早期乳がんの補助療法として承認した。

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.

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