Camizestrant
Camizestrant (Etcamah, AstraZeneca AB ) 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 | + 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 |
Full text of section 4.1 (therapeutic indications)
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). In pre- or peri-menopausal women and in men, Etcamah plus a CDK4/6 inhibitor should be combined with a luteinizing hormone releasing hormone (LHRH) agonist or antagonist.
Label history
There is no record of changes to the Etcamah label that oncolabels can read yet. EMA publishes it some months after the first approval.