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.
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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.