Elacestrant
Elacestrant (Orserdu, Stemline Therapeutics B.V.) has 1 EU-approved indication in 1 tumour type. It needs a biomarker result: ESR1 (1).
| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| Breast cancer1 | |||
ESR1 mutation, ER-positive, HER2-negative | Monotherapy | 2L advanced | After at least one line of endocrine therapy including a CDK 4/6 inhibitor; Postmenopausal women, and men |
Full text of section 4.1 (therapeutic indications)
ORSERDU 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 one line of endocrine therapy including a CDK 4/6 inhibitor.
Label history
6 changes to the Orserdu label since 2024, none of them to the indications. Newest first, in the words of EMA's record of each procedure.
Changes