FDA Approves Novartis Kisqali® Femara® Co-Pack to treat metastatic breast cancer

Novartis has announced that its Kisqali Femara Co-Pack, the first, and only currently available, combination pack with two prescription products in advanced breast cancer has received approval from the US Food and Drug Administration (FDA).

The Kisqali Femara Co-Pack (ribociclib tablets; letrozole tablets) is used to treat hormone receptor-positive, human epidermal growth factor receptor-2 negative (HR+ / HER2-) advanced or metastatic breast cancer in postmenopausal women.

Kisqali (ribociclib) is a selective, cyclin-dependent kinase inhibitor that decelerates the progression of cancer by inhibiting two proteins called cyclin-dependent kinase 4 and 6 (CDK4/6). It is developed by the Novartis Institutes for BioMedical Research (NIBR) under a research collaboration with Astex Pharmaceuticals.

This pack provides a convenient one package prescribing option for their patients underscores our commitment to deliver innovative treatment solutions to the metastatic breast cancer community.

Now, Physicians in the United States have the flexibility to prescribe Kisqali in two different ways: Via the new Co-Pack or as two separate prescriptions of Kisqali and any aromatase inhibitor.

Patients can benefit from the convenience of obtaining a full 28-day cycle of the two medicines in one package with one prescription and one co-pay through the innovative packaging of the Kisqali Femara Co-Pack.

The Kisqali Femara Co-Pack is available in three dosage strengths: Kisqali 600 mg plus Femara 2.5 mg, Kisqali 400 mg plus Femara 2.5 mg, and Kisqali 200 mg plus Femara 2.5 mg.

Femara (letrozole) is a form of hormone therapy known as an aromatase inhibitor, which reduces the amount of oestrogen produced in the bodies of postmenopausal women. It has been a standard of care option for more than a decade in early and advanced breast cancer.