Novartis' Kisqali gains EU approval as first-line breast cancer treatment

Novartis announced Thursday that the European Commission approved Kisqali (ribociclib) in combination with an aromatase inhibitor for the treatment of postmenopausal women with hormone receptor positive, HER2-negative locally advanced or metastatic breast cancer as initial endocrine-based therapy. The oral CDK4/6 inhibitor, formerly known as LEE011, was cleared by the FDA in March.

EU approval of Kisqali follows a positive opinion granted by the European Medicines Agency's Committee for Medicinal Products for Human Use, which was based on data from the Phase III MONALEESA-2 trial. Results from the study showed that Kisqali plus Femara (letrozole) reduced the risk of disease progression or death by 43 percent versus Femara alone, while median progression-free survival for the two groups was 25.3 months and 16 months, respectively.

FirstWord reports in this therapy area - KOL Insight Breast Cancer: Find out how KOLs expect the market to evolve, which pipeline treatments are most promising, and which clinical trials will shape treatment decisions. Learn more.

According to Novartis, Kisqali is taken orally once-daily at a suggested starting dose of 600 mg for three weeks, followed by one week off treatment. The drug, which was developed by the Novartis Institutes for BioMedical Research under a research collaboration with Otsuka's Astex Pharmaceuticals subsidiary, is taken in combination with continuous use of any aromatase inhibitor.

Novartis is also studying Kisqali in the Phase III MONALEESA-3 and MONALEESA-7 trials evaluating the drug in combination with multiple endocrine therapy partners across a broad range of patients, including premenopausal women. Further studies are investigating Kisqali with endocrine therapy as adjuvant therapy in pre- and postmenopausal women who have not previously received treatment with CDK4/6 or aromatase inhibitors.

For related analysis, see The First Take: Pipeline therapies for triple-negative breast cancer – KOLs speak out.

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