FDA Approval: Ribociclib for the Treatment of Postmenopausal Women with Hormone Receptor–Positive, HER2-Negative Advanced or Metastatic Breast Cancer
Cet article présente les données ayant conduit la FDA à approuver l'utilisation du ribociclib pour traiter les patientes atteintes d'un cancer du sein HR + HER2- de stade avancé ou métastatique après la ménopause, et analyse notamment les données d'un essai randomisé international évaluant l'efficacité, du point de vue du taux de réponse globale et de la survie sans progression, et la toxicité de l'ajout du ribociclib au létrozole
On March 13, 2017, the FDA approved ribociclib (KISQALI; Novartis Pharmaceuticals Corp.), a cyclin-dependent kinase 4/6 inhibitor, in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor (HR)–positive, HER2-negative advanced or metastatic breast cancer. The approval was based on a randomized, double-blind, placebo-controlled, international clinical trial (MONALEESA-2). A total of 668 patients were randomized to receive either ribociclib plus letrozole (n = 334) or placebo plus letrozole (n = 334). An improvement in progression-free survival (PFS) was observed in patients receiving ribociclib plus letrozole compared with patients receiving placebo plus letrozole [HR = 0.556; 95% confidence interval (CI), 0.429–0.720]. Overall response rate (ORR) in patients with measurable disease was 52.7% (95% CI, 46.6–58.9) in the ribociclib plus letrozole arm and 37.1% (95% CI, 31.1–43.2) in the placebo plus letrozole arm. Overall survival data were immature. The most common adverse reactions observed in 20% or more of patients taking ribociclib were neutropenia, nausea, fatigue, diarrhea, leukopenia, alopecia, vomiting, constipation, headache, and back pain. This article summarizes FDA decision-making and data supporting the approval of ribociclib. Clin Cancer Res; 24(13); 1–6. ©2018 AACR.See related commentary by Spring and Bardia, p. xxx