Novartis (NVS) said Wednesday that the European Commission has approved its drug Kisqali in combination with an aromatase inhibitor as an adjuvant treatment for patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative early breast cancer at high risk of recurrence.
The approval of the drug, also called ribociclib, is based on results from a 20-country, 5,101-patient phase III trial which showed a 25.1% reduction in risk of disease recurrence compared with endocrine therapy alone, the company said.
The news follows the recent US Food and Drug Administration approval of Kisqali for early breast cancer patients, the company said.
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