345 mg
Trade Name
ORSERDU
Film coated tablet
Request Type
Registration
Drug Type
New Drug
Approval Date
SFDA Approved Use
Elacestrant Dihydrochloride monotherapy is indicated for the treatment of postmenopausal women, and men, with estrogen receptor (ER)-positive, HER2-negative, locally advanced or metastatic breast cancer with an activating ESR1 mutation who have disease progression following at least line of endocrine therapy including a CDK 4/6 inhibitor for at least 12 months.
This indication is approved based on progression free survival. Continued approval of this indication may be contingent upon verification and description of clinical benefit (overall survival) in the confirmatory trials.
This indication is approved based on progression free survival. Continued approval of this indication may be contingent upon verification and description of clinical benefit (overall survival) in the confirmatory trials.