Generic Name: ribociclib

Pronunciation: N/A

Abbreviation: N/A

Other Market Name: N/A

Drug Class: Targeted Therapy Medications

Company: Novartis

Approval Status: Approved

Generic Version Available: No

Experimental Code: LEE001

Drug Indication

Kisqali is a CDK4/6 kinase inhibitor approved for the treatment of hormone receptor-positive, HER2-negative advanced or metastatic breast cancer in combination with hormone therapy.

General Info

Kisqali inhibits cyclin-dependent kinases 4 and 6 (CDK4/6), which play a role in cell growth and division. Blocking these kinases interferes with breast cancer growth.

The MONALEESA-2 trial showed that Kisqali plus the aromatase inhibitor Femara (letrozole) improved progression-free survival (PFS) in postmenopausal women with hormone receptor-positive (HR+), HER2-negative advanced or metastatic breast cancer who were receiving hormone therapy for the first time. MONALEESA-2 showed that Kisqali plus Faslodex (fulvestrant) extended PFS in postmenopausal women who were either on their first hormone therapy or progressed during or after hormone therapy. MONALEESA-7 showed that Kisqali plus either an aromatase inhibitor or tamoxifen plus Zoladex (goserelin) to suppress ovarian function extended PFS in pre- or perimenopausal women. Kisqali was first approved in 2017.


Dosing Info:

Kisqali is taken as a capsule once daily with or without food. It is usually taken for three weeks followed by a week off.

Side Effects

Common side effects include nausea and vomiting, fatigue, diarrhea, hair loss, skin rash and constipation. Kisqali can cause depletion of white blood cells (neutropenia), which can lead to infections. Potentially serious side effects include heart rhythm abnormalities and liver toxicity. Kisqali should not be used during pregnancy.

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Last Reviewed: December 4, 2018