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Frontline Ribociclib Approved in Europe for HR+/HER2- Breast Cancer

Jason M. Broderick @jasoncology
Published: Thursday, Aug 24, 2017

Wolfgang Janni, MD, PhD

Wolfgang Janni, MD, PhD
The European Commission (EC) has approved the CDK 4/6 inhibitor ribociclib (Kisqali) for use in combination with an aromatase inhibitor for the frontline treatment of postmenopausal women with hormone-receptor (HR)–positive, HER2-negative locally advanced or metastatic breast cancer.

In the United States, the FDA approved the frontline combination of ribociclib and an aromatase inhibitor for patients with HR+/HER2-negative advanced breast cancer in March 2017, also based on findings from the MONALEESA-2 study.
Hortobagyi GN, Stemmer SM, Burris HA, et al. Updated results from MONALEESA-2, a phase 3 trial of first-line ribociclib + letrozole in hormone receptor-positive (HR+), HER2-negative (HER2–), advanced breast cancer (ABC). J Clin Oncol. 2017;35 (suppl; abstr 1038).

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