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Switzerland : Novartis Kisqali (ribociclib) receives EU approval as first-line treatment for HR+/HER2- locally advanced or metastatic breast cancer in combination with any aromatase inhibitor.

Novartis announced that the European Commission (EC) approved Kisqali (ribociclib) in combination with an aromatase inhibitor for treatment of postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) locally advanced or metastatic breast cancer as initial endocrine-based therapy. Kisqali is the first CDK4/6 inhibitor approved in Europe based on a first-line Phase III trial that met its primary endpoint of progression-free survival (PFS) at interim analysis.

"This approval of Kisqali reinforces our recognized leadership in cancer research and our commitment to innovative targeted therapies," said Bruno Strigini, CEO, Novartis Oncology. "We are proud of our collaboration with study investigators and patients, which provides the medical community with an important new treatment option for women with advanced or metastatic breast cancer."

EU approval follows a positive opinion granted in June by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), which was based on superior efficacy and demonstrated safety of Kisqali plus letrozole versus letrozole alone in the pivotal Phase III MONALEESA-2 trial. The opinion included a recommendation that allows oncologists the flexibility to prescribe Kisqali with any aromatase inhibitor (i.e., letrozole, anastrozole or exemestane) they deem most appropriate for their patient.

"Advanced breast cancer remains incurable, so it's important to start with a powerful treatment option at initial diagnosis," said Wolfgang Janni, MD, PhD, University of Ulm, MONALEESA-2 investigator. "I am encouraged that women in Europe living with HR+/HER2- advanced breast cancer may be treated in first-line with ribociclib in combination with letrozole, which demonstrated strong progression-free survival of more than two years in the pivotal MONALEESA-2 trial."

MONALEESA-2 enrolled 668 postmenopausal women with HR+/HER2- advanced or metastatic breast cancer who received no prior systemic therapy for their advanced breast cancer and showed that Kisqali plus letrozole, an aromatase inhibitor, reduced the risk of progression or death by 43% over letrozole alone (median PFS=25.3 months (95% CI: 23.0-30.3) vs. 16.0 months (95% CI: 13.4-18.2); HR=0.568 (95% CI: 0.457-0.704; p

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Publication:Mena Report
Date:Aug 28, 2017
Words:358
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