Health Canada has approved Novartis’ Kisqali (ribociclib) in combination with an aromatase inhibitor for the initial treatment for advanced or metastatic breast cancer in which postmenopausal women are hormone receptor (HR)–positive, human epidermal growth factor receptor 2 (HER2)-negative.
The approval was largely based on results of the phase 3 multi-national MONALEESA-2 trial that included 8 Canadian sites. In that study, the progressive-free survival rate after 18 months was 63% in the Kisqali group compared to 42.2% for the control group.
Kisqali is a protein kinase inhibitor that stops cancer cells from dividing and growing. It is to be used in combination with letrozole, an aromatase inhibitor that reduces the levels of estrogen. The two drugs in combination should slow down the growth and spread of breast cancer cells.
In a news release, Dr. Susan Dent, M.D., Medical Oncologist at The Ottawa Hospital Cancer Centre said “For women living with advanced breast cancer, the arrival of ribociclib as a new therapy option is promising news for patients.” Dr. Dent added, “Advanced breast cancer has no cure, however effective treatment can help delay disease progression.”
Cathy Ammendolea, Chair of the Board of Directors, Canadian Breast Cancer Network noted, “We know that for many women living with metastatic breast cancer and their families, it can make a significant difference when a new treatment option is available.”
Although Health Canada has approved Kisqali, the drug still has to be reviewed by pan-Canadian Oncology Drug Review (pCODR) to determine if it should be recommended to public pharmacy plans.
Last year, Novartis announced that the United Kingdom’s National Institute for Health and Care Excellence (NICE) recommended the drug as a cost-effective treatment. Fingers crossed pCODR) has a similar assessment.