- FDA approves Novartis’s Kisqali (ribociclib) with an aromatase inhibitor for HR+/HER2- stage II and III early breast cancer at high recurrence risk.
- The Phase III NATALEE trial showed a 25% reduction in recurrence risk. Kisqali, already used for metastatic breast cancer, is taken daily for three weeks on, one week off, for three years.
- The safety profile is well-tolerated. This approval expands treatment options, offering a significant tool to reduce recurrence risk in early-stage breast cancer.
- Regulatory reviews continue globally.
Tue Sep 17 16:00:51 -0000 2024 UTC– FDA approves Novartis Kisqali for high-risk HR+/HER2- early breast cancer patients, reducing recurrence risk by 25%. Approval is based on Phase III NATALEE trial showing benefits in all patient subgroups. Kisqali, a CDK4/6 inhibitor, taken for three years with an aromatase inhibitor.
Adverse events include neutropenia and liver-related issues. NATALEE trial data presented at ESMO showed a 28.5% reduction in recurrence risk. Novartis offers patient support program. Kisqali approved for metastatic breast cancer globally and under review for early breast cancer worldwide. Novartis aims to improve breast cancer treatment and patient outcomes.