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  • Expanded indication for Kisqali in early breast cancer
  • by Son, Hyung Min | translator Hong, Ji Yeon | Aug 26, 2025 06:05am
as an adjuvant therapy
Kisqali combination therapy group had reduced risk of invasive disease progression or death by 28.5% compared to the endocrine therapy monotherapy group
invasive disease-free survival (iDFS) was 88.5% at the 4th year¡¦statistically significant improvement in effectiveness
 ¡ã Kisqali
On August 22, Novartis Korea (CEO and President Byeong-jae Yoo) announced that its CDK 4/6 inhibitor, Kisqali, was approved for a new indication from the Ministry of Food and Drug Safety for use as an adjuvant therapy in patients with HR+ (hormone receptor-positive)/HER2- (human epidermal growth factor receptor 2-negative) Stage II and III early breast cancer who are at high risk of recurrence.

Kisqali has now expanded indications from advanced and metastatic breast cancer to include early breast cancer, thereby broadening treatment options.

The current expanded indication is based on the results of the global Phase 3 clinical trial, NATALEE. The NATALEE study was a randomized, multi-center, open-label clinical
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