Kisqali Wins FDA Approval As First-line Treatment for Metastatic Breast Cancer

Novartis has received the FDA’s approval for Kisqali for use in combination with an aromatase inhibitor for treatment of postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer.

The FDA approval was based on a phase 3 trial of Kisqali plus letrozole versus letrozole alone.

Kisqali is administered in a once-daily oral dose of 600 mg (three 200 mg tablets) for three weeks, followed by one week off treatment. The product is taken in combination with four weeks of any aromatase inhibitor.