FDA Approves Combination Pack for Treatment of Breast Cancer

The US Food and Drug Administration has approved Kisqali Femara Co-Pack (ribociclib tablets and letrozole tablets), which contains 2 treatments for advanced breast cancer in postmenopausal women. This is the first combination pack approved by the FDA for the treatment of hormone receptor-positive, human epidermal growth factor receptor-2 negative advanced or metastatic breast cancer.
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Kisqali Femara Co Pack contains a 28-day cycle of both ribociclib tablets and letrozole tablets. Kisqali (ribociclib) is cyclin-dependent kinase inhibitor that was approved in March of this year for the treatment of advanced breast cancer with an aromatase inhibitor, and Femara (letrozole) is an aromatase inhibitor that was approved in 1997.

Currently, combination dosages of 600 mg of kisqali and 2.5 mg of Femara, 400 mg of Kisqali and 2.5 mg of Femara, and 200 mg Kisqali and 2.5 mg Femara are available.

The combination pack gives physicians the option to write one prescription for both drugs, which is purchased by the patient under one co-pay, or the option to write 2 prescriptions for Kisqali and any aromatase inhibitor.

—Melissa Weiss

Reference:

Novartis receives FDA approval for first-of-its-kind Kisqali® Femara® Co-Pack for initial treatment of HR+/HER2- advanced or metastatic breast cancer [press release]. East Hanover, NJ: Novartis; May 8, 2017. https://www.pharma.us.novartis.com/news/media-releases/novartis-receives-fda-approval-first-its-kind-kisqalir-femarar-co-pack-initial.