# Tarlatamab

Tarlatamab (Imdylltra, Amgen Europe B.V.) has 1 EU-approved indication in 1 tumour type.

## Approved indications

### Small cell lung cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | Monotherapy | 2nd line, advanced | Disease progression on or after first-line treatment with platinum-based chemotherapy; Who require systemic therapy |

## Products

### Imdylltra

- Company: Amgen Europe B.V.
- Target: DLL3 × CD3 bispecific antibody
- Class: Other monoclonal antibodies and antibody drug conjugates
- ATC: L01FX33
- EU approval: 29 May 2026
- Label revised: 23 Jun 2026
- Status: orphan medicine
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/imdylltra-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/imdylltra-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/imdylltra

Mechanism (SmPC section 5.1): Binds DLL3 on tumor cells and CD3 on T cells, triggering T-cell activation and release of cytotoxic proteins to lyse DLL3-positive tumor cells.

## Label wording

- **Tarlatamab** (Imdylltra), Small cell lung cancer, 2nd line, advanced: “IMDYLLTRA is indicated as monotherapy for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC), who require systemic therapy following disease progression on or after first-line treatment with platinum-based chemotherapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/imdylltra-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/tarlatamab