EMA — authorised 3 February 2025
- Application: EMEA/H/C/006170
- Marketing authorisation holder: Accord Healthcare S.L.U.
- Local brand name: Hetronifly
- Indication: Small cell lung cancer (SCLC) 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). Non-small cell lung carcinoma (NSCLC) Hetronifly in combination with carboplatin and pemetrexed is indicated for the first-line treatment of adult non-squamous NSCLC patients with no EGFR, ALK or ROS1 positive mutations and who have: locally advanced NSCLC who are not candidates for surgery or radiotherapy, or metastatic NSCLC. Oesophageal squamous cell carcinoma (OSCC) Hetronifly in comb
- Status: approved
The European Medicines Agency (EMA) granted marketing authorisation for Hetronifly (HLX10) on 3 February 2025. Hetronifly is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) in combination with carboplatin and etoposide. It is also indicated for the first-line treatment of adult non-squamous non-small cell lung carcinoma (NSCLC) patients with no EGFR, ALK or ROS1 positive mutations, and for unresectable, locally advanced, recurrent or metastatic oesophageal squamous cell carcinoma whose tumours express PD-L1 with a CPS ≥ 5, in combination with fluoropyrimidine- and platinum-based chemotherapy.