FDA Approves First-of-its-kind Kisqali Femara Co-Pack For Treatment BreastCancer

Cancer Connect

The US Food and Drug Administration (FDA) has approved the Kisqali ®Femara ® Co-Pack (ribociclib tablets; letrozole tablets) for the treatment of hormone receptor-positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer in postmenopausal women 1. The Kisqali-Femara Co-Pack is the first, and only currently available, combination pack with two prescription products in advanced breast cancer.

With this FDA approval, physicians in the United States now have the flexibility to prescribe Kisqali two different ways: via the new Co-Pack or as two separate prescriptions of Kisqali and any aromatase inhibitor.

The packaging of the Kisqali-Femara Co-Pack allows patients the convenience of obtaining a full 28-day cycle of the two medicines in one package with one prescription and one co-pay. The Kisqali-Femara Co-Pack is available at the same cost as Kisqali alone.  The Kisqali-Femara Co-Pack will be available in the US later this month at both specialty and retail pharmacies, and does not change the indication for either medicine.

Kisqali was approved in March 2017 in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with HR+/HER2- advanced or metastatic breast cancer 2. Femara is an aromatase inhibitor approved for first-line treatment of postmenopausal women with HR+ or unknown advanced breast cancer 3. Developed by Novartis, Femara has been a standard of care option for more than a decade in early and advanced breast cancer.

About Kisqali ® is a selective cyclin-dependent kinase inhibitor, a class of drugs that help slow the progression of cancer by inhibiting two proteins called cyclin-dependent kinase 4 and 6 (CDK4/6). These proteins, when over-activated, can enable cancer cells to grow and divide too quickly. Targeting CDK4/6 with enhanced precision may play a role in ensuring that cancer cells do not continue to replicate uncontrollably.

About Femara® is a form of hormone therapy known as an aromatase inhibitor, which works by reducing the amount of estrogen produced in the bodies of postmenopausal women. Femara was first approved in 1997 for treatment of postmenopausal women with HR+ or unknown advanced breast cancer that progressed after anti-estrogen therapy. In 2001, Femara was approved as first-line treatment of postmenopausal women with HR+ or unknown locally advanced or metastatic breast cancer.


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