# Elranatamab

Elranatamab (Elrexfio, Pfizer Europe MA EEIG) has 1 EU-approved indication in 1 tumour type.

## Approved indications

### Multiple myeloma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | Monotherapy | 3rd line+ | After at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody, and demonstrated disease progression on the last therapy |

## Products

### Elrexfio

- Company: Pfizer Europe MA EEIG
- Target: BCMA × CD3 bispecific antibody
- EU approval: 7 Dec 2023
- Label revised: 16 Jan 2026
- Status: conditional approval, PRIME
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/elrexfio-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/elrexfio-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/elrexfio

Mechanism (SmPC section 5.1): Binds BCMA on myeloma cells and CD3 on T cells, activating T cells, releasing proinflammatory cytokines, and lysing multiple myeloma cells.

## Label wording

- **Elranatamab** (Elrexfio), Multiple myeloma, 3rd line+: “ELREXFIO is indicated as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/elrexfio-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/elranatamab