FDA Breakthrough Therapy designation for Kisqali for pre- or peri-menopausal women with HR+/HER2- advanced or metastatic breast cancer.- Novartis.

Novartis announced Kisqali (ribociclib) received FDA Breakthrough Therapy designation for initial endocrine-based treatment of pre- or peri-menopausal 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.

This Breakthrough Therapy designation is based on positive results of the Phase III MONALEESA-7 trial demonstrating Kisqali in combination with tamoxifen or an aromatase inhibitor as initial endocrine-based therapy significantly prolonged progression-free survival (PFS) compared to endocrine therapy alone (median PFS 23.8 (95% CI: 19.2 months-not reached) vs. 13.0 months (95% CI: 11.0-16.4 months); HR=0.553; 95% CI: 0.441-0.694; p<0.0001). a total of 672 women ranging from 25-58 years in age were enrolled and randomized in the trial. all treatment combinations also included goserelin. treatment benefit with kisqali combination therapy was consistent compared to the overall population regardless of treatment with tamoxifen or aromatase inhibitor endocrine partners, and across predefined patient subgroups.>

Comment: Premenopausal breast cancer is a biologically distinct and more aggressive disease than postmenopausal breast cancer, and it is the leading cause of cancer death in women 20-59 years old.