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

 

Novartis has received FDA approval for its Kisqali Femara Co-Pack, a combination pack of two prescription products for advanced breast cancer treatment. The Co-Pack contains ribociclib tablets and letrozole tablets, which are used to treat hormone receptor-positive, HER2-negative advanced or metastatic breast cancer in postmenopausal women.

Kisqali is a selective inhibitor of cyclin-dependent kinase 4 and 6 (CDK4/6) and is developed by Novartis Institutes for BioMedical Research in collaboration with Astex Pharmaceuticals. The Co-Pack provides a convenient prescribing option, allowing physicians to prescribe Kisqali either via the Co-Pack or as separate prescriptions of Kisqali and an aromatase inhibitor.

The innovative packaging of the Kisqali Femara Co-Pack allows patients to receive a full 28-day cycle of both medicines with one prescription and co-pay. The Co-Pack is available in three dosage strengths, offering flexibility in treatment options. Femara, an aromatase inhibitor, is included in the Co-Pack to reduce estrogen production in postmenopausal women and has been a standard of care for breast cancer for over a decade.