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FDA Grants Ribociclib Breakthrough Designation for HR+/HER2- Premenopausal Breast Cancer

Jason M. Broderick @jasoncology
Published: Wednesday, Jan 03, 2018

Samit Hirawat, executive vice president and head, Global Drug Development at Novartis Oncology
Samit Hirawat
The FDA has granted ribociclib (Kisqali) a breakthrough therapy designation for use in combination with tamoxifen or an aromatase inhibitor (AI) as frontline treatment for pre- or perimenopausal women with hormone receptor–positive, HER2-negative advanced or metastatic breast cancer.

Ribociclib is currently approved by the FDA  for use in combination with an aromatase inhibitor for the frontline treatment of postmenopausal women with hormone-receptor–positive, HER2-negative advanced breast cancer.
Tripathy D, Sohn J, Im SA, et al. First-line ribociclib vs placebo with goserelin and tamoxifen or a non-steroidal aromatase inhibitor in premenopausal women with hormone receptor-positive, HER2-negative advanced breast cancer: results from the randomized phase III MONALEESA-7 trial. Presented at: the 2017 San Antonio Breast Cancer Symposium; Dec. 5-9, 2017. Abstract GS2-05.

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