Ribociclib

FDA expands approval of breast cancer drug Kisqali to earlier stages, increasing access for tens of thousands.

FDA approves Novartis' Kisqali for HR+/HER2- stage II and III early breast cancer, significantly expanding eligible patient population.

The FDA expanded approval of Novartis' Kisqali for early-stage breast cancer, reducing recurrence risk by 25% after 3 years and 28.5% after 4 years. Available for HR-positive, HER2-negative cases, it broadens treatment options beyond high-risk patients. However, the cost is high, potentially $300,000-$400,000 over 3 years.

FDA approves Novartis’ Kisqali for earlier stages of HR-positive/HER2-negative breast cancer, doubling eligible patient population. Kisqali, in combination with an aromatase inhibitor, reduces recurrence risk by 28.5% in NATALEE trial.

Novartis’ Kisqali (ribociclib) approved by FDA for early breast cancer treatment in combination with an aromatase inhibitor for HR-positive/HER2-negative stage 2 and 3 patients at high risk of recurrence. Supported by NATALEE trial results showing reduced recurrence risk by 25.1% with Kisqali plus endocrine therapy versus endocrine therapy alone, with benefits extending beyond three years.

FDA expands Kisqali use for early-stage breast cancer, reducing recurrence risk by 25% after 3 years and 28.5% after 4 years in HR-positive, HER2-negative cases. Available for broader patient groups, it complements endocrine therapy, though costs up to $400,000 over 3 years.

FDA approves ribociclib (Kisqali) with endocrine therapy as adjuvant treatment for early high-risk HR-positive/HER2-negative breast cancer, expanding eligible patients for CDK4/6 inhibitor therapy. NATALEE trial results show 25% reduction in disease recurrence risk with ribociclib plus aromatase inhibitor, with consistent subgroup benefits. Adverse events consistent with known safety profile.

FDA approves Kisqali (ribociclib) for HR+/HER2- stage II and III early breast cancer, reducing recurrence risk by 25% with endocrine therapy. NATALEE trial results show consistent benefits and well-tolerated safety profile across subgroups, including node-negative patients. Kisqali is under regulatory review worldwide.

FDA approves Kisqali, a CDK4/6 inhibitor by Novartis, for early-stage breast cancer, expanding its use to include stage 2 and 3 HR positive, HER2 negative patients without positive lymph nodes. Kisqali, combined with hormone therapy, aims to reduce recurrence risk by 28.5% over endocrine therapy alone, as shown in the NATALEE trial. Common side effects include low white blood cell counts and joint pain, and it is administered for three years post-surgery.

The FDA approved Kisqali with an aromatase inhibitor for postsurgical treatment of HR-positive, HER2-negative early breast cancer at high risk of recurrence. The efficacy was demonstrated in the phase 3 NATALEE trial, showing improved invasive disease-free survival. Side effects included neutropenia, liver-related issues, QT interval prolongation, and interstitial lung disease/pneumonitis.