The Committee for Medicinal Products for Human Use (CHMP), a part of the European Medicines Agency (EMA), recommended approval of ribociclib (Kisqali) for use in combination with an aromatase inhibitor as a first-line treatment for postmenopausal women with hormone receptor (HR)-positive /HER2-negative locally advanced or metastatic breast cancer.
The most common nonhematologic AEs (all grades) were nausea (51.5% with ribociclib vs 28.5% with placebo), infections (50.3% vs 42.4%), fatigue (36.5% vs 30.0%), and diarrhea (35% vs 22.1%). The events were grade 1/2 severity in most cases. Rates of discontinuation were 7.5% with ribociclib and 2.1% with placebo.
- Hortobagyi GN, Stemmer SM, Burris HA, et al. First-line ribociclib + letrozole for postmenopausal women with hormone receptor-positive, HER2-negative, advanced breast cancer. Presented at: 2016 ESMO Congress; October 7-11, 2016; Copenhagen, Denmark. Abstract LBA1.
- Hortobagyi GN, Stemmer SM, Burris HA, et al. Ribociclib as first-line therapy for HR-positive, advanced breast cancer [published online October 8, 2016]. N Engl J Med. doi:10.1056/NEJMoa1609709.
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