Posted by Michael Wonder on 03 Jan 2018
Novartis Kisqali received FDA breakthrough therapy designation for initial endocrine-based treatment in pre-menopausal women with HR+/HER2- advanced breast cancer
3 January 2017 - Designation based on Phase III MONALEESA-7 results demonstrating superior efficacy of Kisqali in combination with oral endocrine therapy compared to oral endocrine therapy in pre- or peri-menopausal women who received no prior endocrine therapy for advanced disease.
Novartis today announced Kisqali (ribociclib) received US FDA breakthrough therapy designation for initial endocrine-based treatment of pre- or perimenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer in combination with tamoxifen or an aromatase inhibitor.
