# Carfilzomib

Carfilzomib (Kyprolis, Amgen Europe B.V.) has 3 EU-approved indications in 1 tumour type.

## Approved indications

### Multiple myeloma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | + daratumumab and dexamethasone | 2nd line | After at least one prior therapy |
| None | + dexamethasone | 2nd line | After at least one prior therapy |
| None | + lenalidomide and dexamethasone | 2nd line | After at least one prior therapy |

## Products

### Kyprolis

- Company: Amgen Europe B.V.
- Target: Proteasome inhibitor
- Class: Other antineoplastic agents
- ATC: L01XX45
- EU approval: 19 Nov 2015
- Label revised: 5 Aug 2026
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/kyprolis-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/kyprolis-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/kyprolis

Mechanism (SmPC section 5.1): Selectively and irreversibly binds the active sites of the 20S proteasome, inhibiting proteasome activity and inducing proapoptotic and antiproliferative effects.

## Label wording

- **Carfilzomib** (Kyprolis), Multiple myeloma, 2nd line: “Kyprolis in combination with daratumumab and dexamethasone, with lenalidomide and dexamethasone, or with dexamethasone alone is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior therapy (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/kyprolis-epar-product-information_en.pdf)
- **Carfilzomib** (Kyprolis), Multiple myeloma, 2nd line: “Kyprolis in combination with daratumumab and dexamethasone, with lenalidomide and dexamethasone, or with dexamethasone alone is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior therapy (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/kyprolis-epar-product-information_en.pdf)
- **Carfilzomib** (Kyprolis), Multiple myeloma, 2nd line: “Kyprolis in combination with daratumumab and dexamethasone, with lenalidomide and dexamethasone, or with dexamethasone alone is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior therapy (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/kyprolis-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/carfilzomib