The U.S. Food and Drug Administration (FDA) has accepted Novartis’s New Drug Application (NDA) for ribociclib, in combination with letrozole, as a first-line treatment of postmenopausal women with hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer, and has granted the application Priority Review.1
Submission was based on findings from the phase 3 MONALEESA-2 trial (ClinicalTrials.gov Identifier: NCT01958021), which showed that ribociclib plus letrozole reduced the risk of disease progression or death by 44% (hazard ratio, 0.556; 95% CI, 0.429-0.720; P = .00000329) compared with letrozole alone. Median progression-free survival had not yet been reached (95% CI, 19.3-not estimable) in the ribociclib arm and was 14.7 months (95% CI, 13.0-16.5) in the letrozole plus placebo arm.
The international, double-blind study randomly assigned 668 postmenopausal patients with HR-positive, HER2-negative advanced breast cancer who received no prior treatment for advanced disease to receive ribociclib plus letrozole or placebo plus letrozole.
Priority Review designation requires that the FDA take action on an application within 6 months of its filing date instead of the 10 months required under standard review.
Ribociclib is an investigational selective cyclin dependent kinase inhibitor that inhibits cyclin dependent kinases 4 and 6. Targeting these proteins reduces cancer cell proliferation.
- Novartis LEE011 (ribociclib) granted FDA Priority Review for first-line treatment of HR+/HER2- advanced breast cancer. Novartis website. https://www.novartis.com/news/media-releases/novartis-lee011-ribociclib-granted-fda-priority-review-first-line-treatment. Updated November 1, 2016. Accessed November 1, 2016.