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6-K: FDA Approves Novartis Kisqali® to Reduce Risk of Recurrence in People with HR+/HER2- Early Breast Cancer

6-K: FDA Approves Novartis Kisqali® to Reduce Risk of Recurrence in People with HR+/HER2- Early Breast Cancer

6-K:FDA批准诺华诺德Kisqali® 以降低 HR+/HER2-早期乳腺癌患者的复发风险
美股SEC公告 ·  2024/09/17 18:09

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The FDA has approved Kisqali (ribociclib) in combination with aromatase inhibitor for adjuvant treatment of HR+/HER2- stage II and III early breast cancer at high risk of recurrence. The approval is based on the Phase III NATALEE trial results showing a significant 25.1% reduction in disease recurrence risk compared to endocrine therapy alone, with consistent benefits across all patient subgroups including node-negative disease.The 400mg daily dosing regimen demonstrated a well-tolerated safety profile during the three-year treatment period. Recent ESMO Congress 2024 data showed further improvement with a 28.5% reduced recurrence risk beyond the treatment period. Key adverse events included neutropenia (62.5%), liver-related events (26.4%), and QT interval prolongation (5.3%).This approval approximately doubles the population eligible for CDK4/6 inhibitor adjuvant therapy, addressing a critical need as about 90% of breast cancer cases are diagnosed early, with significant recurrence risks despite current treatments. Kisqali is under regulatory review worldwide, including in the EU and China, building on its established profile in metastatic breast cancer where it is approved in 99 countries.
The FDA has approved Kisqali (ribociclib) in combination with aromatase inhibitor for adjuvant treatment of HR+/HER2- stage II and III early breast cancer at high risk of recurrence. The approval is based on the Phase III NATALEE trial results showing a significant 25.1% reduction in disease recurrence risk compared to endocrine therapy alone, with consistent benefits across all patient subgroups including node-negative disease.The 400mg daily dosing regimen demonstrated a well-tolerated safety profile during the three-year treatment period. Recent ESMO Congress 2024 data showed further improvement with a 28.5% reduced recurrence risk beyond the treatment period. Key adverse events included neutropenia (62.5%), liver-related events (26.4%), and QT interval prolongation (5.3%).This approval approximately doubles the population eligible for CDK4/6 inhibitor adjuvant therapy, addressing a critical need as about 90% of breast cancer cases are diagnosed early, with significant recurrence risks despite current treatments. Kisqali is under regulatory review worldwide, including in the EU and China, building on its established profile in metastatic breast cancer where it is approved in 99 countries.
FDA已批准Kisqali(ribociclib)与芳香化酶抑制剂联合用于高复发风险的HR+/HER2- II和III期早期乳腺癌的辅助治疗。批准基于III期NATALEE试验结果,显示相比单独内分泌疗法,疾病复发风险显著降低25.1%,所有患者亚组,包括淋巴结阴性疾病,均持续受益。400mg的每日剂量在三年的治疗期间显示了良好的耐受性安全性。最近的2024年欧洲肿瘤内科学大会数据进一步显示,治疗期结束后复发风险降低了28.5%。主要不良事件包括中性粒细胞减少症(62.5%)、肝相关事件(26.4%)和QT间期延长(5.3%)。此项批准使有资格接受CDK4/6抑制剂辅助治疗的人群近乎翻倍,解决了一个关键需求,因为约90%的乳腺癌病例在早期被诊断,尽管目前的治疗存在显著的复发风险。Kisqali正在全球范围内进行监管审核,包括在欧盟和中国,建立在其在转移性乳腺癌中的既有声誉基础上,已在99个国家获批。
FDA已批准Kisqali(ribociclib)与芳香化酶抑制剂联合用于高复发风险的HR+/HER2- II和III期早期乳腺癌的辅助治疗。批准基于III期NATALEE试验结果,显示相比单独内分泌疗法,疾病复发风险显著降低25.1%,所有患者亚组,包括淋巴结阴性疾病,均持续受益。400mg的每日剂量在三年的治疗期间显示了良好的耐受性安全性。最近的2024年欧洲肿瘤内科学大会数据进一步显示,治疗期结束后复发风险降低了28.5%。主要不良事件包括中性粒细胞减少症(62.5%)、肝相关事件(26.4%)和QT间期延长(5.3%)。此项批准使有资格接受CDK4/6抑制剂辅助治疗的人群近乎翻倍,解决了一个关键需求,因为约90%的乳腺癌病例在早期被诊断,尽管目前的治疗存在显著的复发风险。Kisqali正在全球范围内进行监管审核,包括在欧盟和中国,建立在其在转移性乳腺癌中的既有声誉基础上,已在99个国家获批。
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本页的译文内容由软件翻译。Moomoo将竭力但却不能保证翻译内容之准确和可靠,亦不会承担因任何不准确或遗漏而引起的任何损失或损害。