FDA approves first drug for ESR1-mutated breast cancer

Reviewed by Emily Henderson, B.Sc.Feb 9 2023

Dr. Rajkumar Lakshmanaswamy, Ph.D., Chair of the Department of Molecular and Translational Medicine, Center of Emphasis in Cancer and Dean of the L. Frederick Francis Graduate School of Biomedical Sciences at Texas Tech University Health Sciences Center El Paso is available to speak on the Federal Drug Administration's approval of the selective estrogen receptor (ER) degrader elacestrant (Orserdu).

This is a treatment for postmenopausal women or adult men with ER-positive, HER2-negative, ESR1-mutated advanced, or metastatic breast cancer with disease progression following at least one line of endocrine therapy.

The FDA also approved the Guardant360 CDx assay as a companion diagnostic test to identify patients for treatment with elacestrant. As many as 40% of ER-positive, HER2-negative breast cancers are associated with ESR1 mutations.

Dr. Lakshmanaswamy has done research on breast cancer, and how hormones regulate the growth of tumors.