FDA approves Stemline's Orserdu

The US Food and Drug Administration (FDA) on Friday announced the approval of the  investigational oral selective estrogen receptor degrader (SERD) Orserdu (elacestrant) 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 drug was developed by privately-held Italian drugmaker Menarini and its wholly-owned US subsidiary Stemline Therapeutics, to which the approval was granted.

This application was granted priority review and fast track designation