Novartis Breast Cancer drug Kisqali wins market approval in European Union as first-line treatment for HR+/HER2-

European Medicines Agency (EMA) panel approves Kisqali (CDK4/6 inhibitor ribociclib) in combination with hormone therapy as a first-line treatment for hormone receptor positive, human epidermal growth factor receptor-2 negative locally advanced or metastatic breast cancer.

FDA has already cleared Kisqali in March 2017.

This approval challenges the market share of rival, Pfizer's Ibrance which is in market since 2015.

Kisqali is sold in US packaged with aromatase inhibitor letrozole but, the Committee for Medicinal Products for Human Use (CHMP) recommends combining Kisqali with any aromatase inhibitor like letrozole, anastrozole or exemestane, giving the physician the discretion to select the therapy they believe is most appropriate for each individual patient.

This approval is based on results of a pivotal Phase III  MONALEESA-2 trial that showed Kisqali plus letrozole reduced risk of disease progression or death by 44% over letrozole alone among postmenopausal women with HR+/HER2- advanced breast cancer.

After nearly one year of additional follow-up, Kisqali plus letrozole demonstrated median progression-free survival (PFS) of 25.3 months compared to 16.0 months for placebo in combination with letrozole.

Bruno Strigini, CEO, Novartis Oncology said, "This positive CHMP opinion brings us one step closer to improving the lives of women diagnosed with advanced or metastatic breast cancer throughout Europe. There is currently no cure for advanced breast cancer, and approximately 30 percent of those affected by early-stage breast cancer will go on to develop advanced disease.”