# Linvoseltamab

Linvoseltamab (Lynozyfic, Regeneron Ireland Designated Activity Company (DAC)) 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 3 prior therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody, and disease progression on the last therapy; Relapsed and refractory |

## Products

### Lynozyfic

- Company: Regeneron Ireland Designated Activity Company (DAC)
- Target: BCMA × CD3 bispecific antibody
- Class: Other monoclonal antibodies and antibody drug conjugates
- ATC: L01FX
- EU approval: 23 Apr 2025
- Label revised: 22 Jul 2025
- Status: conditional approval
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/lynozyfic-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/lynozyfic-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/lynozyfic

Mechanism (SmPC section 5.1): It binds CD3 on T cells and BCMA on malignant myeloma cells, triggering T-cell activation and redirected lysis of BCMA-expressing cells.

## Label wording

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