KISQALI (ribociclib), protein kinase inhibitor (CDK 4/6)

High clinical benefit but no proven clinical added value with respect to the first-line therapeutic strategy for advanced metastatic HR+/HER2- breast cancer, in menopausal women, in the absence of short-term life-threatening symptomatic visceral involvement.

Insufficient clinical benefit to justify reimbursement in combination with anastrozole or exemestane and/or in the presence of short-term life-threatening symptomatic visceral involvement.

• KISQALI has been granted a marketing authorisation in combination with an aromatase inhibitor for the initial hormone therapy-based treatment of menopausal women with advanced hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer.

• In exchange for a higher toxicity in terms of neutropoenia, hepatobiliary and cardiac disorders, adding ribociclib to letrozole prolongs the median progression-free survival by 9.3 months (25.3 months in the letrozole + ribociclib group versus 16 months in the letrozole + placebo group) in menopausal female patients previously untreated for advanced-stage breast cancer and not having received aromatase inhibitor as part of adjuvant therapy in the previous 12 months. No gain in overall survival or in quality of life has been demonstrated to date.

• It is not possible to determine the benefit and clinical added value of ribociclib in the context of a combination other than with letrozole and/or in cases of short-term life-threatening symptomatic visceral involvement failing efficacy and safety data.