# Ixazomib

Ixazomib (Ninlaro, Takeda Pharma A/S) has 1 EU-approved indication in 1 tumour type.

## Approved indications

### Multiple myeloma

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

## Products

### Ninlaro

- Company: Takeda Pharma A/S
- Target: Proteasome inhibitor
- Class: Proteasome inhibitors
- ATC: L01XG03
- EU approval: 21 Nov 2016
- Label revised: 5 Aug 2026
- Status: orphan medicine
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/ninlaro-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/ninlaro-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/ninlaro

Mechanism (SmPC section 5.1): Oral prodrug whose active form reversibly binds and inhibits the chymotrypsin-like activity of the 20S proteasome beta 5 subunit, inducing tumour cell apoptosis.

## Label wording

- **Ixazomib** (Ninlaro), Multiple myeloma, 2nd line: “NINLARO in combination with lenalidomide and dexamethasone is indicated 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/ninlaro-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/ixazomib