# Lurbinectedin

Lurbinectedin (Zepzelca, Pharma Mar S.A.) has 1 EU-approved indication in 1 tumour type.

## Approved indications

### Small cell lung cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | + atezolizumab | Maintenance, advanced | After first-line induction therapy with atezolizumab, carboplatin and etoposide without disease progression |

## Products

### Zepzelca

- Company: Pharma Mar S.A.
- Target: DNA-binding transcription inhibitor
- Class: Other antineoplastic agents
- ATC: L01XX69
- EU approval: 29 May 2026
- Label revised: 1 Jun 2026
- Status: orphan medicine
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/zepzelca-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/zepzelca-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/zepzelca

Mechanism (SmPC section 5.1): Binds CG-rich DNA sequences in gene promoters, evicts oncogenic transcription factors and stalls elongating RNA polymerase II, causing its degradation, cell cycle arrest and tumour cell apoptosis.

## Label wording

- **Lurbinectedin** (Zepzelca), Small cell lung cancer, maintenance, advanced: “ZEPZELCA, in combination with atezolizumab, is indicated for the maintenance treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed after first-line induction therapy with atezolizumab, carboplatin and etoposide.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/zepzelca-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/lurbinectedin