Ribociclib

1 for selection criteria). In pre- or perimenopausal women, or in men, the aromatase inhibitor should be combined with a luteinising hormone-releasing hormone (LHRH) agonist. Advanced or metastatic breast cancer Kisqali is indicated for the treatment of women with HR-positive, HER2-negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine- based therapy, or in women who have received prior endocrine therapy.

In pre- or perimenopausal women, the endocrine therapy should be combined with a LHRH agonist.

1 for selection criteria). In pre- or perimenopausal women, or in men, the aromatase inhibitor should be combined with a luteinising hormone-releasing hormone (LHRH) agonist. Advanced or metastatic breast cancer Kisqali is indicated for the treatment of women with HR-positive, HER2-negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine- based therapy, or in women who have received prior endocrine therapy.

In pre- or perimenopausal women, the endocrine therapy should be combined with a LHRH agonist. 3

Early breast cancer KISQALI® (ribociclib tablets) is indicated: • In combination with an aromatase inhibitor for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II-III early breast cancer at high risk of recurrence.

In pre- or perimenopausal women, or men, the aromatase inhibitor should be combined with a luteinizing hormone-releasing hormone (LHRH) agonist. Advanced or metastatic breast cancer KISQALI® (ribociclib tablets) is indicated, in combination with: • an aromatase inhibitor for the treatment of pre/perimenopausal or postmenopausal women, or men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)- negative advanced or metastatic breast cancer, as initial endocrine-based therapy; • In pre/perimenopausal women, or men, the endocrine therapy should be combined with a luteinizing hormone releasing hormone (LHRH) agonist.

• fulvestrant for the treatment of postmenopausal women, with HR-positive, HER2-negative advanced or metastatic breast cancer, as initial endocrine-based therapy or following disease progression on endocrine therapy. 1 Pediatrics Pediatrics (≤ 18 years of age): Health Canada has not authorized an indication for pediatric use.