▎WuXiEdited by Kant Content Team
Novartis announced today that the U.S. FDA hasApproval of CDK4/6 inhibitor Kisqali (ribociclib) in combination with aromatase inhibitors (AI) as adjuvant therapy for patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) stage II and III early breast cancer (EBC) at high risk of recurrence., including patients without lymph node metastasis (N0).
This approval is based on the positive results of the pivotal Phase 3 clinical trial NATALEE,In HR+/HER2- early breast cancer patients receiving Kisqali combined with endocrine therapy (ET) as adjuvant treatment, the risk of recurrence was significantly and clinically meaningfully reduced by 25.1% compared to those receiving ET alone (HR=0.749; 95% CI: 0.628, 0.892; P=0.0006)., including N0 patients with high risk. Improvement in invasive disease-free survival (iDFS) was consistently observed across all patient subgroups.
The latest analysis of the NATALEE trial, recently presented at the 2024 European Society for Medical Oncology (ESMO) Congress, further solidified the data under FDA review. The results showed,After three years of treatment, patients benefited further, with the risk of recurrence reduced by 28.5% (HR=0.715; 95% CI: 0.609, 0.840; P<0.0001) in the Kisqali combination therapy group compared to patients receiving ET alone.Novartis will continue to evaluate the long-term outcomes of NATALEE patients, including overall survival.
Approximately 90% of breast cancer cases are diagnosed at an early stage (I-III) and promptly treated with curative intent. Nevertheless, patients with stage II and III HR+/HER2- early breast cancer still face the risk of cancer recurrence, most often as incurable metastatic disease. The majority of recurrences happen within the first few years after initial treatment, even in patients without lymph node involvement. Despite endocrine therapy (ET), 10% of high-risk N0 patients may experience a recurrence within three years of diagnosis. "With this approval, we are redefining treatment options for a broad population affected by breast cancer and facing ongoing risks of recurrence," said Mr. Victor Bultó, President of Novartis US.
▲ To learn more about the application of cutting-edge technologies in the biopharmaceuticals industry, please long press or scan the QR code above to access "WuXi Live Studio" and watch live discussions and exciting replays on related topics.
[1] FDA approves Novartis Kisqali® to reduce risk of recurrence in people with HR+/HER2- early breast cancer. Retrieved September 17, 2024, from https://www.globenewswire.com/news-release/2024/09/17/2947737/0/en/FDA-approves-Novartis-Kisqali-to-reduce-risk-of-recurrence-in-people-with-HR-HER2-early-breast-cancer.htmlDisclaimer: The content team of WuXi AppTec focuses on introducing the research progress in global biopharmaceuticals and health. This article is for information exchange purposes only, and the views expressed in the article do not represent the position of WuXi AppTec, nor does it indicate that WuXi AppTec supports or opposes these views. This article is not a recommendation for treatment plans. For guidance on treatment options, please visit a正规 hospital.Copyright Statement: This article is from the content team of WuXi AppTec. Individuals are welcome to share it on their social media circles, but unauthorized reproduction by media or institutions in any form to other platforms is prohibited. For authorization to reproduce, please reply with "reprint" on the "WuXi AppTec" WeChat Official Account to obtain reprint guidelines.
Share，PointLike，In View, Focusing on Global Biomedical Health Innovation
