Ribociclib is used for selected breast-cancer populations. Regulatory indications differ by country, so the applicable local prescribing information should always be consulted.
Early breast cancer
Current U.S. labeling indicates ribociclib with an aromatase inhibitor for the adjuvant treatment of adults with HR-positive, HER2-negative stage II and III early breast cancer at high risk of recurrence.
The European authorization similarly covers HR-positive/HER2-negative early breast cancer at high risk of recurrence, with selection criteria described in the European product information.
Advanced or metastatic breast cancer
In the United States, ribociclib is indicated for adults with HR-positive, HER2-negative advanced or metastatic breast cancer in combination with:
- An aromatase inhibitor as initial endocrine-based therapy; or
- Fulvestrant as initial endocrine-based therapy or following disease progression on endocrine therapy.
Premenopausal and perimenopausal patients
European product information states that when Kisqali is used in premenopausal or perimenopausal women, endocrine therapy should be combined with an LHRH agonist. Similar principles apply to men under the applicable labeling.
Approved versus investigational use
Clinical research involving ribociclib does not automatically establish a regulatory indication. Treatment decisions should be based on the indication authorized in the relevant jurisdiction.
Clinical evidence
The MONALEESA program evaluated ribociclib across multiple advanced-breast-cancer populations. MONALEESA-2 reported longer overall survival with ribociclib plus letrozole than with placebo plus letrozole, while MONALEESA-3 and MONALEESA-7 also reported overall-survival benefits in their respective populations.