# Camizestrant

Camizestrant (Etcamah, AstraZeneca AB ) has 1 EU-approved indication in 1 tumour type. It needs a biomarker result: ESR1 (1).

## Approved indications

### Breast cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| ESR1 mutation, ER-positive, HER2-negative | + a CDK4/6 inhibitor (palbociclib, ribociclib, or abemaciclib) | 1st line, 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 |

## Products

### Etcamah

- Company: AstraZeneca AB 
- Target: Selective estrogen receptor degrader (SERD)
- Class: Anti-estrogens
- ATC: L02BA05
- EU approval: 20 Jul 2026
- Label revised: 21 Jul 2026
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/etcamah-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/etcamah-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/etcamah

Mechanism (SmPC section 5.1): Oral SERD that binds the ERα ligand-binding domain, antagonising wild-type and ESR1-mutant ERα and inducing its proteasome-dependent degradation without agonist activity.

## Label wording

- **Camizestrant** (Etcamah), Breast cancer, 1st line, advanced: “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).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/etcamah-epar-product-information_en.pdf)

Source: section 4.1 of each summary of product characteristics (SmPC), EMA data as of 5 Nov 2026. AI models structured these entries and no person has checked them yet. oncolabels is a non-commercial reference for education and research and gives no medical advice; the current SmPC takes precedence.

Data under CC BY 4.0: credit oncolabels and the European Medicines Agency. Page: https://oncolabels.com/drugs/camizestrant
