First-line treatment of HR+/HER2- advanced or metastatic breast cancer.
Cyclin dependent kinase (CDK) inhibitor.
600 mg PO once daily on days 1-21 each 28-day cycle; give with letrozole 2.5 mg/day PO on days 1-28.
Approval was based on interim analysis results from the pivotal phase 3 MONALEESA-2 trial in postmenopausal women who received no prior systemic therapy for their advanced breast cancer (n=668). Interim results showed progression-free survival (PFS) rate was 63% with a duration of 19.3 months with ribociclib plus letrozole, compared with a rate of 42.2% and a duration of 14.7 months in the letrozole-alone group. Since these data were published, a subsequent analysis with an additional 11 months of follow-up showed that the median PFS was 25.3 months with the ribociclib combination compared with 16 months with letrozole alone.
O’Shaughnessy J, et al. Ribociclib plus letrozole versus letrozole alone in patients with de novo HR+, HER2- advanced breast cancer in the randomized MONALEESA-2 trial. Breast Cancer Res Treat. 2017 Nov 21.
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Cite this: Mary L Windle. FDA New Drug and Biologic Approvals -- 2017 Year-in-Review - Medscape - Jan 11, 2018.