European Commission (EC) approved Novartis’s 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.
Novartis said that 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.
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 company said.
“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.”
To remind, in March 2017, the US Food and Drug Administration (FDA) approved Kisqali, in combination with any aromatase inhibitor, as a treatment for metastatic breast cancer.