ORSERDU (A Menarini Australia Pty Ltd)
Product name
ORSERDU
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
110 (120 working days)
Active ingredients
elacestrant dihydrochloride
Registration type
NCE/NBE
Indication
ORSERDU monotherapy is indicated for the treatment of postmenopausal women, and men, with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer with an activating ESR1 mutation who have disease progression following at least one line of endocrine therapy including a CDK 4/6 inhibitor.