# AL amyloidosis

The EU has approved 1 indication of 1 drug in AL amyloidosis. None of them needs a biomarker result.

## Approved indications

### No biomarker required

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Daratumumab](https://oncolabels.com/drugs/daratumumab) (Darzalex) | None | + cyclophosphamide, bortezomib and dexamethasone | 1st line | - |

## Label wording

- **Daratumumab** (Darzalex), AL amyloidosis, 1st line: “DARZALEX is indicated in combination with cyclophosphamide, bortezomib and dexamethasone for the treatment of adult patients with newly diagnosed systemic AL amyloidosis.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/darzalex-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/tumours/al-amyloidosis