Ribociclib, a CDK4/6 inhibitor intended to prevent runaway cell growth, received FDA approval Monday for treating postmenopausal women with advanced or metastatic hormone receptor-positive, HER2-negative breast cancer, .
To be sold as Kisqali, the drug is to be used in combination with an aromatase inhibitor.
Approval was based primarily on the phase III MONALEESA-2 trial, comparing ribociclib plus letrozole (Femara) to letrozole alone. The addition of ribociclib reduced the risk of progression or death by 44% during follow-up. Median progression-free survival was ultimately determined to be 25.3 months with the combination, compared with 16 months with letrozole alone.
A once-daily oral drug, ribociclib is given in 4-week cycles: 3 weeks of treatment followed by 1 week off.