EC approves Novartis’ breast cancer drug Kisqali
Swiss drugmaker Novartis’ Kisqali (ribociclib) has received approval from the European Commission (EC) as a first-line treatment for advanced breast cancer.
This current decision is applicable to all 28 EU member states, as well as Iceland, Norway and Liechtenstein.
Kisqali can be used in combination with an aromatase inhibitor in postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+ / HER2-) locally advanced or metastatic breast cancer.
The drug is a selective cyclin-dependent kinase inhibitor that can be administered orally once-daily and helps slow down the progression of cancer by inhibiting two proteins, cyclin-dependent kinase 4 and 6 (CDK4/6).
Novartis oncology CEO Bruno Strigini said: “This approval of kisqali reinforces our recognised leadership in cancer research and our commitment to innovative targeted therapies.
“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.”
The current approval comes after a positive opinion granted by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in June this year.
The CHMP opinion is based on efficacy and safety demonstrated by kisqali plus letrozole versus letrozole alone in the pivotal Phase III Monaleesa-2 trial, which involved 668 postmenopausal women with HR+ / HER2- advanced or metastatic breast cancer who received no prior systemic therapy.
Developed by the Novartis Institutes for BioMedical Research (NIBR) as part of a research collaboration with Astex Pharmaceuticals, the treatment can be used in combination with letrozole, anastrozole or exemestane.