How this therapy can help
Kisqali® is a selective CDK inhibitor, a new class of drugs that help slow the progression of cancer by inhibiting two proteins called CDK 4 and 6 (CDK4/6). These proteins, when over-activated in a cell, can enable cancer cells to grow and divide too quickly.
Kisqali® received US marketing approval by the FDA in March 2017 as a first-line drug treatment for HR+/HER2- advanced breast cancer in combination with an aromatase inhibitor. For full prescribing and safety information please see here.
Kisqali® is currently being evaluated by Novartis in combination with a number of other endocrine agents as part of the ongoing MONALEESA (Mammary ONcology Assessment of LEE011’s Efficacy and SAfety) clinical trial program.
The MONALEESA-2 Phase 3 randomized, double blind, placebo controlled, multicenter global registration trial to evaluate the safety and efficacy of Kisqali® in combination with letrozole compared to letrozole alone in postmenopausal women with HR+/HER2- advanced breast cancer who received no prior therapy for their advanced breast cancer met its primary endpoint at the pre-planned interim analysis due to superior efficacy compared to letrozole alone.
MONALEESA-3 is a trial evaluating Kisqali® in combination with fulvestrant compared to fulvestrant alone in men and post-menopausal women with HR+/HER2- advanced breast cancer who have received no or a maximum of one prior endocrine therapy. MONALEESA-3 is fully enrolled.
MONALEESA-7 is a trial investigating Kisqali® in combination with endocrine therapy and goserelin compared to endocrine therapy and goserelin alone in pre-menopausal women with HR+/HER2- advanced breast cancer who have not previously received endocrine therapy. MONALEESA-7 is fully enrolled and is the only Phase 3 study that focuses solely on pre- and peri-menopausal women with advanced breast cancer.