Kisqali Approved to Treat Breast Cancer
March 13, 2017 - The U.S. FDA approved Kisqali® (ribociclib) as a breakthrough therapy and ahead of schedule. Manufactured by Novartis, Kisqali is indicated as first-line treatment for postmenopausal women who have metastatic or advanced hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) breast cancer. It selectively inhibits cyclin-dependent kinase (CDK) 4 and 6 (CDK4/6), enzymes that promote the growth and spreading of cancer cells. It will be used in combination with an aromatase inhibitor, such as anastrozole, exemestane or letrozole. Kisqali will be available in 200mg tablets and the recommended dosing is based on four-week cycles, with 600mg (three tablets) of Kisqali taken once daily for 21 days, then stopped for the next seven days. The aromatase inhibitor is taken continually without a break.
Kisqali may cause QT prolongation, which is an abnormal heartbeat that may lead to death. A baseline electrocardiogram (ECG) should be taken before treatment begins, about halfway through the first treatment cycle, at the start of the second cycle and then periodically during treatment. Additionally, electrolyte levels should be tested at the beginning of the first six cycles and then at regular intervals. Liver function also should be checked before starting therapy, every two weeks during the first two cycles, at the start of the next four cycles and then as considered appropriate.
The wholesale acquisition cost of a 28-day supply of the 600mg dose is anticipated to be about $10,950, or approximately $142,700 per year. Currently, the only other CDK4/6 inhibitor that is FDA approved for treating breast cancer is Pfizer’s Ibrance® (palbociclib). Ibrance is indicated for use only with letrozole, not with other aromatase inhibitors and it does not require heart or liver monitoring.
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- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
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