Two New Indications of Kisqali Approved in US for Advanced Breast Cancers

Two New Indications of Kisqali Approved in US for Advanced Breast Cancers
Kisqali (ribociclib) now can be used in combination with an aromatase inhibitor as first-line therapy for all women with HR-positive, HER2-negative advanced or metastatic breast cancer in the United States, regardless of their menopausal status, according to Novartis. This combination already was approved for postmenopausal women with HR-positive, HER2-negative breast cancer, and the label expansion makes Kisqali the first CDK4/6 inhibitor indicated for women in all menopausal stages, including those who have not reached menopause (premenopausal) or who are in menopause transition (perimenopausal). In addition, the U.S. Food and Drug Administration (FDA) also approved Kisqali in combination with Faslodex (fulvestrant) as first- or second-line therapy for postmenopausal women with HR-positive, HER2-negative advanced breast cancer. "Compelling data for Kisqali have led to the broadest first-line indications of any CDK4/6 inhibitor," Liz Barrett, CEO, Novartis Oncology, said in a press release. "With this new approval Kisqali has the potential to help even more people in the U.S. live a longer life without progression of disease from this incurable form of breast cancer." The approval was supported by data from the MONALEESA-7 (
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