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EMA Product

Hetronifly

Product approved by European Medicines Agency (EU)

Basic Information

Hetronifly

Regulatory Information

EMEA/H/C/006170

Authorised

February 3, 2025

September 19, 2024

2

May 5, 2025

Company Information

Spain

Edificio Este Planta 6a World Trade Center Moll De Barcelona S/n 08039 Barcelona

ACCORD HEALTHCARE SL

Drug Classification

Orphan MedicineAdditional Monitoring

Active Substances Detail

Detailed Information

Therapeutic Indication

### Therapeutic indication Hetronifly in combination with carboplatin and etoposide is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).

Overview Summary

Hetronifly is a cancer medicine used in adults to treat small cell lung cancer (SCLC) that has grown extensively in the lung or spread to other parts of the body (extensive-stage SCLC) and has not been treated previously. It is given together with carboplatin and etoposide (chemotherapy medicines). SCLC is rare, and Hetronifly was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 09 December 2022. Further information on the orphan designation can be found on the EMA [website](https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-22-2731). Hetronifly contains the active substance serplulimab.

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