NOVARTIS

The FDA approved adjuvant ribociclib (Kisqali) plus an aromatase inhibitor for HR-positive, HER2-negative stage II and III early breast cancer with high recurrence risk, based on NATALEE trial data showing improved invasive disease-free survival. The combination achieved 3-year iDFS rates of 90.4% vs 87.1% with endocrine therapy alone, with benefits sustained over 44.2 months of follow-up.

PD-1 inhibition with pembrolizumab before and after surgery significantly improves 5-year overall survival (86.6% vs 81.7%) in high-risk early triple-negative breast cancer, according to KEYNOTE-522 trial results.

The FDA approved ribociclib (Kisqali) with an aromatase inhibitor for adjuvant treatment of HR+, HER2- stage II and III early breast cancer at high risk of recurrence. The approval was based on the NATALEE trial, which showed a 90.7% invasive disease-free survival rate at 36 months with ribociclib plus NSAI versus 87.6% with NSAI alone. Ribociclib inhibits CDK 4/6 proteins to slow cancer progression.

The FDA approved adjuvant ribociclib (Kisqali) plus an aromatase inhibitor for hormone receptor–positive, HER2-negative stage II and III early breast cancer, based on the NATALEE trial showing improved invasive disease-free survival. The combination achieved a 3-year iDFS rate of 90.4% vs 87.1% with endocrine therapy alone, with benefits sustained over 44.2 months.

The FDA approved ribociclib plus an aromatase inhibitor as adjuvant treatment for HR-positive, HER2-negative early breast cancer at high risk of recurrence, based on NATALEE trial data showing reduced recurrence risk by 28.5%.

Ribociclib (Kisqali) in combination with an aromatase inhibitor received FDA approval for adjuvant treatment of HR+/HER2- stage 2 and 3 EBC at high risk of recurrence, based on the NATALEE trial data showing a 25% reduction in risk of disease recurrence and well-tolerated safety.

FDA expands approval of Kisqali for early-stage HR-positive, HER2-negative breast cancer, reducing recurrence risk by 25% after 3 years and 28.5% after 4 years. Available to broader patient groups than Verzenio, it may cause fewer side effects and offers hope to younger women with rising breast cancer rates.

FDA approves Kisqali (ribociclib) with aromatase inhibitor for HR+/HER2- stage II and III EBC at high risk of recurrence, based on NATALEE trial showing 25% reduced risk of recurrence vs. endocrine therapy alone, with consistent benefit across subgroups.