Novartis won U.S. FDA approval for Kisqali (ribociclib) for the treatment of breast cancer

Kisqali (ribociclib)

Novartis won U.S. FDA approval for Kisqali (ribociclib) for the treatment of breast cancer


U.S. FDA (Food and Drug Administration) recently approved Novartis drug Kisqali (ribociclib) for the treatment of breast cancer.

Company: Novartis

Specific Treatments: Breast cancer

Therapeutic Areas: Gynecology (Women’s Health)/Obstetrics, Oncology



General Information about Kisqali (ribociclib)

Kisqali (ribociclib) is a kinase inhibitor.

Kisqali is specifically indicated in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)- negative advanced or metastatic breast cancer. 


KIsqali is supplied as a tablet for oral administration. The recommended dose of Kisqali is 600 mg (three 200 mg film-coated tablets) taken orally, once daily for 21 consecutive days followed by 7 days off treatment resulting in a complete cycle of 28 days. Kisqali can be taken with or without food. Coadminister Kisqali with letrozole 2.5 mg taken once daily throughout the 28-day cycle. Refer to the full prescribing information of letrozole. For dosing and administration with other aromatase inhibitors refer to the applicable full prescribing information. Patients should take their dose of Kisqali and letrozole at approximately the same time each day, preferably in the morning. If the patient vomits after taking the dose, or misses a dose, no additional dose should be taken that day. The next prescribed dose should be taken at the usual time. Kisqali tablets should be swallowed whole (tablets should not be chewed, crushed or split prior to swallowing).


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