# Teclistamab

Teclistamab (Tecvayli) has 2 EU-approved indications in 1 tumour type.

## Approved indications

### Multiple myeloma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | + daratumumab | 2nd line | After at least one prior therapy; Relapsed or refractory |
| None | Monotherapy | 3rd line+ | After at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody; disease progression on the last therapy; Relapsed and refractory |

## Products

### Tecvayli

- Target: BCMA × CD3 bispecific antibody
- Class: Other monoclonal antibodies and antibody drug conjugates
- ATC: L01FX24
- EU approval: 23 Aug 2022
- Label revised: 27 Aug 2026
- Status: PRIME
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/tecvayli-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/tecvayli-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/tecvayli

Mechanism (SmPC section 5.1): Teclistamab binds CD3 on T cells and BCMA on myeloma cells, bringing them together to trigger T-cell activation and subsequent lysis of BCMA-positive cells.

## Label wording

- **Teclistamab** (Tecvayli), Multiple myeloma, 2nd line: “in combination with daratumumab for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior therapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tecvayli-epar-product-information_en.pdf)
- **Teclistamab** (Tecvayli), Multiple myeloma, 3rd line+: “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/tecvayli-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/teclistamab