Serplulimab

Serplulimab (Hetronifly, Accord Healthcare S.L.U.) has 4 EU-approved indications in 3 tumour types. 1 needs a biomarker result: PD-L1 (1).

Approved indications of Serplulimab
Biomarker requirement	Regimen	Setting	Conditions

Small cell lung cancer1
None	+ carboplatin and etoposide	1L advanced	None

Non-small cell lung cancer2
None	+ carboplatin and nab-paclitaxel	1L advanced	Squamous only
EGFR/ALK/ROS1 negative	+ carboplatin and pemetrexed	1L advanced	Non-squamous only; Not candidates for surgery or radiotherapy (if locally advanced)

Oesophageal cancer1
PD-L1 CPS ≥ 5	+ fluoropyrimidine- and platinum-based chemotherapy	1L advanced	Squamous cell carcinoma only

Full text of section 4.1 (therapeutic indications)

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. HETRONIFLY in combination with carboplatin and nab-paclitaxel is indicated for the first-line treatment of adult patients with unresectable, locally advanced or metastatic squamous non-small cell lung carcinoma. 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.

Label history

8 changes to the Hetronifly label since 2025, 3 of them to the indications. Newest first, in the words of EMA's record of each procedure.