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

SEC ·  Sep 17, 2024 18:09

Summary by Moomoo AI

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.
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