← Drug database

Hetronifly (serplulimab)

Region

🇪🇺 EU

Active substance

serplulimab

Company

Accord Healthcare S.L.U.

Status

Authorised

Therapeutic area

Small Cell Lung Carcinoma; Carcinoma, Non-Small-Cell Lung; Esophageal Squamous Cell Carcinoma

CHMP opinion

Thu 19 Sep 2024

EU approval

Mon 03 Feb 2025

Designations

Additional monitoring

Application

EMEA/H/C/006170

ATC

L01FF12

Official record

www.ema.europa.eu

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 combination with fluoropyrimidine- and platinum-based chemotherapy is indicated for the first-line treatment of adult patients with unresectable, locally advanced, recurrent or metastatic oesophageal squamous cell carcinoma whose tumours express PD-L1 with a CPS ≥ 5.

Regulatory milestones

No milestones recorded in the last year.

Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.