FDA Expands Approval of Kisqali for Early-Stage Breast Cancer

The drug, previously approved for metastatic cases, now offers a new treatment option for thousands of women with HR-positive, HER2-negative breast cancer.

• Novartis' Kisqali can now be used in combination with hormone therapy for patients with Stage 2 and 3 HR-positive, HER2-negative breast cancer.
• A phase 3 clinical trial showed Kisqali reduces the risk of cancer recurrence by 25% after three years and 28.5% after four years.
• The expanded approval includes patients whose cancer has not spread to nearby lymph nodes, broadening access to the drug.
• While Verzenio, a similar drug, is only approved for high-risk patients, Kisqali will be available to a wider range of early-stage breast cancer patients.
• The cost of Kisqali treatment for three years ranges from $300,000 to $400,000, but expanded approval may increase insurance coverage options.

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