FDA approval: Ribociclib for the treatment of postmenopausal women with hormone receptor-positive, HER2-negative advanced or metastatic breast cancer

Anand Shah, Erik Bloomquist, Shenghui Tang, Wentao Fu, Youwei Bi, Qi Liu, Jingyu Yu, Ping Zhao, Todd R. Palmby, Kirsten B. Goldberg, C. J.George Chang, Paresma Patel, Elleni Alebachew, Amy Tilley, William F. Pierce, Amna Ibrahim, Gideon M. Blumenthal, Rajeshwari Sridhara, Julia Beaver, Richard Pazdur

Research output: Contribution to journalReview article

Abstract

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.

Original languageEnglish (US)
Pages (from-to)2999-3004
Number of pages6
JournalClinical Cancer Research
Volume24
Issue number13
DOIs
StatePublished - Jul 1 2018
Externally publishedYes

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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    Shah, A., Bloomquist, E., Tang, S., Fu, W., Bi, Y., Liu, Q., Yu, J., Zhao, P., Palmby, T. R., Goldberg, K. B., Chang, C. J. G., Patel, P., Alebachew, E., Tilley, A., Pierce, W. F., Ibrahim, A., Blumenthal, G. M., Sridhara, R., Beaver, J., & Pazdur, R. (2018). FDA approval: Ribociclib for the treatment of postmenopausal women with hormone receptor-positive, HER2-negative advanced or metastatic breast cancer. Clinical Cancer Research, 24(13), 2999-3004. https://doi.org/10.1158/1078-0432.CCR-17-2369