FDA approved Kisqali (ribociclib) for Adjuvant Treatment of Early Breast CancerFDA approved Kisqali to treat early breast cancer at high risk of recurrence.

Kisqali (ribociclib) is a kinase inhibitor. The label does not provide further details on mechanism of action.

Kisqali is indicated in combination with an aromatase inhibitor for the adjuvant treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II and III early breast cancer at high risk of recurrence. It is also indicated for HR-positive, HER2-negative advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine-based therapy, or with fulvestrant as initial endocrine-based therapy or following disease progression on endocrine therapy.

For early breast cancer, the recommended starting dose is 400 mg orally (two 200 mg tablets) once daily for 21 consecutive days followed by 7 days off in 28-day cycles. Treatment should continue for 3 years or until disease recurrence or unacceptable toxicity. For advanced or metastatic breast cancer, the recommended starting dose is 600 mg orally (three 200 mg tablets) once daily for 21 consecutive days followed by 7 days off. Kisqali can be taken with or without food. Dose modifications for adverse reactions are provided in the label. Pre/perimenopausal women or men treated with Kisqali plus an aromatase inhibitor or fulvestrant should receive an LHRH agonist.

Trial data not available in label.

The label includes warnings for interstitial lung disease/pneumonitis and cutaneous adverse reactions including severe cutaneous adverse reactions (SCARs). Dose modification and management recommendations are provided for these adverse reactions. No specific contraindications are listed in the provided label text.

Kisqali is a CDK4/6 inhibitor used in combination with endocrine therapy for HR-positive, HER2-negative breast cancer. The adjuvant indication provides a treatment option for patients with stage II and III disease at high risk of recurrence. In advanced/metastatic disease, it is used as initial therapy or after progression.