ESR1
3 EU-approved indications of 3 drugs need a ESR1 result, in 1 tumour type, most of them in breast cancer.
Approved indications3
| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| Breast cancer3 | ||||
Etcamah | ER-positive, HER2-negative | + a CDK4/6 inhibitor (palbociclib, ribociclib, or abemaciclib) | 1L advanced | During first-line endocrine therapy + CDK4/6 inhibitor, before progression; In pre- or peri-menopausal women and in men, should be combined with a LHRH agonist or antagonist |
Orserdu | 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 |
Inluriyo | ER-positive, HER2-negative | Monotherapy | 2L advanced | After prior treatment with an endocrine based regimen; In pre- or perimenopausal women, or men, Inluriyo should be combined with a luteinising hormone-releasing hormone (LHRH) agonist |
ESR1 by tumour
Label wording3
The sentence from section 4.1 of the SmPC that each indication above comes from.
- Camizestrant (Etcamah)
Etcamah in combination with a CDK4/6 inhibitor (palbociclib, ribociclib, or abemaciclib) is indicated for the treatment of adult patients with ER-positive, HER2-negative, locally advanced or metastatic breast cancer upon detection of ESR1-mutation and without disease progression during first-line endocrine therapy in combination with a CDK4/6 inhibitor (for biomarker based patient-selection, see section 4.2 and 5.1).
- Elacestrant (Orserdu)
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.
- Imlunestrant (Inluriyo)
Inluriyo is indicated as monotherapy for the treatment of adult patients with oestrogen receptor (ER)-positive, HER2-negative, locally advanced or metastatic breast cancer with an activating ESR1-mutation, who have disease progression following prior treatment with an endocrine based regimen (for biomarker-based patient selection, see section 4.2).