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FDA grants priority review to LEE011 as part of first-line combination for advanced breast cancer
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The FDA granted priority review to ribociclib for use with letrozole as first-line treatment of postmenopausal women with hormone receptor–positive, HER-2–negative advanced or metastatic breast cancer, according to a press release from the drug’s manufacturer.
The European Medicines Agency also accepted for review the marketing authorization application for ribociclib (LEE011, Novartis) — a cyclin-dependent kinase 4/6 inhibitor — plus letrozole in the same patient population.
“These regulatory milestones, along with the FDA breakthrough therapy designation granted in August, underscore the need for new treatment options for women living with hormone receptor–positive, HER-2–negative advanced breast cancer,” Bruno Strigini, CEO of Novartis Oncology, said in the press release.
The new drug application for included results of the phase 3 MONALEESA-2 trial, presented in October at the European Society for Medical Oncology Congress.
The analysis included data from 668 postmenopausal women previously untreated for their advanced disease. Researchers randomly assigned patients 1:1 to receive 2.5 mg daily letrozole with placebo or 600 mg daily ribociclib.
PFS served as the primary endpoint. Secondary endpoints included OS, overall response rate, clinical benefit rate, health-related quality of life, safety and tolerability.
The combination reduced the risk for progression or death by 44% (HR = 0.56; 95% CI, 0.43-0.72) compared with letrozole alone. Researchers observed prolonged PFS with the combination across all patient subgroups.