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See the DrugPatentWatch profile for kisqali
What makes Kisqali suitable for early-stage breast cancer? Kisqali (ribociclib) belongs to a class of drugs called CDK4/6 inhibitors. These works by blocking proteins that allow cancer cells to grow and divide. It combines with hormone therapy to keep early-stage HR-positive, HER2-negative breast cancer from returning after surgery. How does Kisqali reach early-stage patients? The FDA approved Kisqali for early-stage use in September 2024 based on the NATALEE trial. That study showed ribociclib plus endocrine therapy reduced the risk of recurrence by 25 percent compared with endocrine therapy alone in patients with stage II and III HR-positive, HER2-negative breast cancer. How lang does the duration of treatment differ from late-stage use? Early-stage patients take Kisqali for three years alongside hormone therapy. Late-stage patients keep it until the disease progresses or they are too tolerant of the heart or liver side effects. Why are companies challenging this patent? No challenges filed yet. The patent for ribociclib is held by Novartis and runs through 2031. The company expects to maintain exclusivity until at least 2032.
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