The Food and Drug Administration (FDA) has approved Kisqali Femara Co-Pack (Novartis), a co-packaged product indicated 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 was approved by the FDA in March 2017 for use in combination with an aromatase inhibitor. The Co-Pack contains Kisqali (ribociclib), a kinase inhibitor, and Femara (letrozole), an aromatase inhibitor. The combination oral therapy can be taken with or without food. 

Ribociclib is a cyclin-dependent kinase (CDK) 4 and 6 inhibitor. These kinases are activated upon binding to D-cyclins and play a crucial role in signaling pathways which lead to cell cycle progression and cellular proliferation. Letrozole inhibits the aromatase enzyme by competitively binding to the heme of the CYP450 subunit of the enzyme, resulting in a reduction of estrogen biosynthesis in all tissues. The suppression of estrogen biosynthesis in peripheral tissues and in the cancer tissue itself can therefore be achieved by specifically inhibiting the aromatase enzyme. 

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Kisqali Femara Co-Pack is dispensed as a carton containing 28-day therapy. Each carton contains Kisqali 200mg tablets and Femara 2.5mg tablets. The 3-blister packs contain either 21 Kisqali tablets + 28 Femara tablets or 14 Kisqali tablets + 28 Femara tablets. The single blister pack contains 21 Kisqali tablets + 28 Femara tablets.

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