# Daratumumab

Daratumumab (Darzalex) has 8 EU-approved indications in 2 tumour types.

## Approved indications

### Multiple myeloma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | + bortezomib, lenalidomide and dexamethasone | 1st line | - |
| None | + bortezomib, thalidomide and dexamethasone | 1st line | Eligible for autologous stem cell transplant |
| None | + lenalidomide and dexamethasone, or bortezomib, melphalan and prednisone | 1st line | Ineligible for autologous stem cell transplant |
| None | + lenalidomide and dexamethasone, or bortezomib and dexamethasone | 2nd line | After at least one prior therapy |
| None | + pomalidomide and dexamethasone | 2nd line | After one prior therapy containing a proteasome inhibitor and lenalidomide with lenalidomide refractoriness, or at least two prior therapies including lenalidomide and a proteasome inhibitor with disease progression on or after the last therapy |
| None | Monotherapy | 2nd line | After prior therapy included a proteasome inhibitor and an immunomodulatory agent, and demonstrated disease progression on the last therapy |
| None | Monotherapy | Any line | Smouldering myeloma only (high risk); High risk of developing multiple myeloma |

### AL amyloidosis

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | + cyclophosphamide, bortezomib and dexamethasone | 1st line | - |

## Products

### Darzalex

- Target: Anti-CD38 monoclonal antibody
- Class: CD38 (clusters of differentiation 38) inhibitors
- ATC: L01FC01
- EU approval: 20 May 2016
- Label revised: 21 Jul 2026
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/darzalex-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/darzalex-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/darzalex

Mechanism (SmPC section 5.1): Binds to CD38 on tumour cells, inducing cell lysis via complement-dependent cytotoxicity, ADCC, ADCP, and apoptosis, while depleting immunosuppressive cells.

## Label wording

- **Daratumumab** (Darzalex), Multiple myeloma, 1st line: “in combination with lenalidomide and dexamethasone or with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/darzalex-epar-product-information_en.pdf)
- **Daratumumab** (Darzalex), Multiple myeloma, 1st line: “in combination with bortezomib, thalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/darzalex-epar-product-information_en.pdf)
- **Daratumumab** (Darzalex), Multiple myeloma, 2nd line: “in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/darzalex-epar-product-information_en.pdf)
- **Daratumumab** (Darzalex), Multiple myeloma, 2nd line: “as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor and an immunomodulatory agent and who have demonstrated disease progression on the last therapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/darzalex-epar-product-information_en.pdf)
- **Daratumumab** (Darzalex), Multiple myeloma, 1st line: “in combination with bortezomib, lenalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/darzalex-epar-product-information_en.pdf)
- **Daratumumab** (Darzalex), Multiple myeloma, 2nd line: “in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one prior therapy containing a proteasome inhibitor and lenalidomide and were lenalidomide-refractory, or who have received at least two prior therapies that included lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or after the last therapy (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/darzalex-epar-product-information_en.pdf)
- **Daratumumab** (Darzalex), Multiple myeloma, any line: “DARZALEX as monotherapy is indicated for the treatment of adult patients with smouldering multiple myeloma at high risk of developing multiple myeloma (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/darzalex-epar-product-information_en.pdf)
- **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/drugs/daratumumab