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# CDK4/6 Inhibitors Help in Breast Cancer: FDA Study
- URL: https://www.fdaweb.com/cdk4-6-inhibitors-help-in-breast-cancer-fda-study/
- Published: 2018-07-11T12:00:00.000Z
- Updated: 2026-09-15T00:18:44.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141847

An FDA pooled study of five registration trials of cyclin-dependent kinases 4/6 (CDK4/6) found that all subgroups of patients with estrogen receptor-positive HER2-negative metastatic breast cancer benefited from the addition of the kinases to endocrine therapy. An *ASCOPost* online [story](http://www.ascopost.com/issues/july-10-2018/use-of-cdk4-6-inhibitors-in-metastatic-breast-cancer/?ref=fdaweb.com) says the study results were reported by CDER Division of Oncology medical oncologist **Jennifer Gao** at the 2018 American Society of Clinical Oncology (ASCO) meeting. The FDA results differ from those presented by other researchers at the 2017 European Society for Medical Oncology conference, which said that combination therapy is probably not warranted in all patients.

ASCO says FDA found no particular subsets of patients with greater or lesser benefit from the addition of CDK4/6 inhibitors to endocrine therapy, either in the first-line or second-line setting. “The suggested conclusion is that all patients with hormone receptor-positive, HER2-negative metastatic breast cancer may benefit from this class of agents,” the story says.