KISQALI (ribociclib) - Breast cancer

The clinical benefit of KISQALI 200 mg (ribociclib) film-coated tablet remains substantial:

• in combination with fulvestrant in the treatment of postmenopausal women with HR-positive, HER2-negative locally advanced or metastatic breast cancer, without short-term life-threatening symptomatic visceral involvement, as initial endocrine-based therapy, or following prior endocrine therapy.

• in combination with a nonsteroidal aromatase inhibitor (letrozole or anastrozole) and an LHRH agonist in premenopausal women with HR-positive, HER2-negative locally advanced or metastatic breast cancer, without short-term life-threatening symptomatic visceral involvement, as initial endocrine-based therapy.

KISQALI (ribociclib) in combination with fulvestrant provides a moderate clinical added value (CAV III) compared to fulvestrant alone in the first- or second-line endocrine therapy of RH positive, HER2-negative advanced breast cancer in postmenopausal women without short-term life-threatening symptomatic visceral involvement.

The addition of KISQALI to letrozole or anastrozole and an LHRH agonist provides a moderate clinical added value (CAV III) compared to the combination of a nonsteroidal aromatase inhibitor (letrozole or anastrozole) and an LHRH agonist in the first-line treatment of HR-positive, HER2-negative locally advanced or metastatic breast cancer, in premenopausal women without short-term life-threatening symptomatic visceral involvement.