Regulatory approval
Published by the European Medicines Agency. Approved
The European Medicines Agency (EMA) has authorized camizestrant in combination with a CDK4/6 inhibitor (palbociclib, ribociclib, or abemaciclib) 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. The Product information further states that in pre- or perimenopausal women and in men, camizestrant plus a CDK4/6 inhibitor should be combined with a luteinizing hormone releasing hormone (LHRH) agonist or antagonist.
This is written in the approval document as:
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.
Citation
Therapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.
| Organizations | Biomarkers | Cancer types | Therapies | |
|---|---|---|---|---|
| EMA (1) | ER positive, ESR1 activating variants, HER2-negative | Invasive Breast Carcinoma | Abemaciclib, Camizestrant | |
| EMA (1) | ER positive, ESR1 activating variants, HER2-negative | Invasive Breast Carcinoma | Camizestrant, Palbociclib | |
| EMA (1) | ER positive, ESR1 activating variants, HER2-negative | Invasive Breast Carcinoma | Camizestrant, Ribociclib |
Contributions
| Date | Contributor | Description |
|---|---|---|
| 2026-08-02 | Van Allen lab | Initial curation of into moalmanac-db |
| 2026-07-20 | European Medicines Agency | Indication received approval from the European Commission. |