FDA Approves First-Line Combo Treatment for HR+/HER2- Metastatic Breast Cancer

MARCH 14, 2017
Jennifer Barrett, Assistant Editor

The FDA has approved Novartis’ Kisqali (ribociclib), in combination with an aromatase inhibitor as initial endocrine-based therapy treatment, for the treatment of breast cancer. The drug is indicated for postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer.
The drug was reviewed and approved under the FDA breakthrough therapy designation and priority review programs.
Approval is based on a first-line phase 3 trial (MONALEESA-2), which demonstrated the efficacy of the treatment in improving progression-free survival compared to letrozole alone. The trial, which included 668 postmenopausal women with HR+/HER2- advanced or metastatic breast cancer, reduced the risk of progression or death by 44%. Additionally, more than half of patients taking Kisqali letrozole experienced a tumor burden reduction of at least 30%.
“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,” Gabriel N. Hortobagyi, MD, professor of medicine at the University of Texas MD Anderson Cancer Center and MONALEESA-2 principal investigator, said in a press release.
Kisqali is to be taken as a once-daily dose of 600 mg for a 3-week period, followed by 1 week without treatment. It is taken in combination with 4 weeks of any aromatase inhibitor.
Novartis Kisqali® (ribociclib, LEE011) receives FDA approval as first-line treatment for HR+/HER2- metastatic breast cancer in combination with any aromatase inhibitor [news release]. Basel. Novartis’ website. . Accessed March 14, 2017.