Ribociclib Approved as Front-Line Therapy for HR+/HER2- Breast Cancer

The FDA has approved Novartis’ ribociclib (Kisqali) as first-line for treatment of postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer.

Ribociclib is a CDK4/6 inhibitor that was approved under the Breakthrough Therapy designation and Priority Review programs.

In phase 3 of the MONALEESA-2 trial, the drug met its primary endpoint of demonstrating statistically significant improvement in progression-free survival (PFS) compared with letrozole alone.

“Kisqali is emblematic of the innovation that Novartis continues to bring forward for people with HR+/HER2- metastatic breast cancer,” Bruno Strigini, CEO of Novartis Oncolog, said in a statement. “We at Novartis are proud of the comprehensive clinical program for Kisqali that has led to today's approval and the new hope this medicine represents for patients and their families.”

The MONALEESA-2 trial enrolled 668 postmenopausal women with HR+/HER2- advanced or metastatic breast cancer. The participants had no prior systemic therapy for their cancer and ribociclib plus letrozole, an aromatase inhibitor, reduce the risk of progression or death by 44% compared with letrozole alone.

In addition, more than half of the patients experienced a tumor reduction of at least 30%, according to Gabriel N. Hortobagyi, MD, professor of medicine in the Department of Medical Oncology at the University of Texas MD Anderson Cancer Center.

"These results affirm that combination therapy with a CDK4/6 inhibitor like ribociclib and an aromatase inhibitor should be a new standard of care for initial treatment of HR+ advanced breast cancer,” said Hortobagyi, the principal investigator of MONALEESA-2.