FDA Approves New Option for Advanced or Metastatic Breast Cancer

The FDA recently approved ribociclib (kisqali), in combination with an aromatase inhibitor, as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.

The FDA approved ribociclib, a cyclin-dependent kinase 4/6 inhibitor, based on the results of the randomized, double-blind, placebo-controlled, international clinical trial MONALEESA-2, which included 668 post-menopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer who received no prior therapy for the advanced disease. Participants were divided evenly, and randomly assigned to receive oral doses of either 600 mg (three 200 mg tablets) of ribociclib plus letrozole or placebo plus letrozole once a day for 21 days, followed by 7 days off treatment, with letrozole (2.5 mg) administered orally for 28 days. The treatment was continued until disease progression or patients experienced unacceptable toxicity.
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While overall survival data are immature, results of a pre-planned interim efficacy analysis showed improvements in progression-free survival (investigator-assessed) with a hazard ratio of 0.556 (95% CI: 0.429, 0.720; p<0.0001). Objective response rate was 52.7% (95% CI: 46.6, 58.9) in patients taking ribociclib plus letrozole with measureable disease and 37.1% in patients taking placebo plus letrozole (95% CI: 31.1, 43.2).

The most common adverse reactions were neutropenia, nausea, fatigue, diarrhea, leukopenia, alopecia, vomiting, constipation, headache, abnormal liver function tests, lymphopenia, and back pain, which were observed in 20% or more of patients taking ribociclib.

—Melissa Weiss

Reference:

Ribociclib (Kisqali) [Press Release]. FDA. March 13, 2017. https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm546438.htm.