FDA New Drug and Biologic Approvals -- 2017 Year-in-Review

Mary L Windle, PharmD


January 11, 2018

In This Article

Kisqali (ribociclib) & Kisqali/Femara Copack (ribociclib/letrozole)


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.


Hortobagyi GN, et al. Ribociclib as first-Line therapy for HR-positive, advanced breast cancer. N Engl J Med. 2016 Nov 3;375(18):1738-48.

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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