# Pomalidomide

Pomalidomide (Imnovid (previously Pomalidomide Celgene), Bristol-Myers Squibb Pharma EEIG) has 2 EU-approved indications in 1 tumour type.

## Approved indications

### Multiple myeloma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | + bortezomib and dexamethasone | 2nd line | After at least one prior treatment regimen including lenalidomide |
| None | + dexamethasone | 3rd line+ | After at least two prior treatment regimens, including both lenalidomide and bortezomib, and disease progression on the last therapy; Relapsed and refractory |

## Products

### Imnovid (previously Pomalidomide Celgene)

- Company: Bristol-Myers Squibb Pharma EEIG
- Target: Immunomodulatory agent
- ATC: L04AX06
- EU approval: 5 Aug 2013
- Label revised: 6 Oct 2025
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/imnovid-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/imnovid-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/imnovid
- Biosimilars and generics: Pomalidomide Teva, Pomalidomide Krka, Pomalidomide Accord, Pomalidomide Zentiva, Pomalidomide Viatris

Mechanism (SmPC section 5.1): Pomalidomide binds cereblon to recruit and degrade substrate proteins Aiolos and Ikaros, causing direct myeloma cell apoptosis, anti-angiogenic effects, and immune activation.

## Label wording

- **Pomalidomide** (Imnovid (previously Pomalidomide Celgene)), Multiple myeloma, 2nd line: “Imnovid in combination with bortezomib and dexamethasone is indicated in the treatment of adult patients with multiple myeloma who have received at least one prior treatment regimen including lenalidomide.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/imnovid-epar-product-information_en.pdf)
- **Pomalidomide** (Imnovid (previously Pomalidomide Celgene)), Multiple myeloma, 3rd line+: “Imnovid in combination with dexamethasone is indicated in the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/imnovid-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/pomalidomide