Ribociclib

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.

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.

Kisqali (ribociclib) plus endocrine therapy (ET) reduces recurrence risk by 28.5% in HR+/HER2- early breast cancer, with benefits extending beyond three years and consistent across subgroups, including node-negative patients. Safety remains consistent with previous findings, and regulatory reviews are ongoing worldwide.

FDA approves Kisqali, a ribociclib-based treatment, in combination with an aromatase inhibitor for adjuvant therapy of HR+/HER2- stage II and III early breast cancer patients at high risk of recurrence, including those with node-negative disease. The approval is supported by the Phase III NATALEE trial results, which demonstrated a 25.1% reduction in disease recurrence risk and a well-tolerated safety profile.

FDA approves Novartis' Kisqali for HR+/HER2- early breast cancer to reduce recurrence risk, based on NATALEE trial results showing a 25.1% reduction in recurrence risk with Kisqali plus endocrine therapy vs. endocrine therapy alone.

Novartis' Kisqali, combined with endocrine therapy, reduced breast cancer recurrence risk by 28.5% beyond the three-year treatment period. The company expects an FDA decision on approval this quarter.

Kisqali (ribociclib) + endocrine therapy (ET) reduces recurrence risk by 28.5% beyond 3 years in HR+/HER2- early breast cancer, with consistent iDFS benefits across subgroups, including node-negative disease. Safety aligns with prior findings, and FDA action is expected in Q3.